Simple 31901 User manual

www.simplemedical.cn
深圳简单医疗科技有限公司
产品说明书
手指固定器
产品型号：31901 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：手指固定器
1.2 产品型号：31901
1.3 产品规格：F
1.4 产品结构：
手指固定器主要由透气柔软的大身，支撑器，绑带等
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。所述产
品特别轮廓的大身和支撑器，能够舒适的为拇指提供最
大限度的支撑和限制拇指的运动，柔软面料的大身为患
者提供舒适的佩戴度。帮助缓解有关拇指关节的疼痛与
重复性压力。
1.6 适用范围
轻度至中度拇指关节扭伤和拉伤，术后愈合及其他软组
织损伤恢复固定支撑。
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】产品简单，穿戴方便，舒适透气。
【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:松开全部绑带，把手放进固定器里面（图 a）。
步骤 2：将绑带#1 穿过绑带孔后再系紧（图 b）。
步骤 3：将拇指绑带#2 穿过绑带孔后再系紧（图 c）。
步骤 4：系紧绑带#3（图 d）
注意：绑带不要系太紧，请根据需要调整绑带的松紧度
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。
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)大身材料：氨纶，尼龙，聚酯 PU
2)支撑器：聚丙烯
3）绑带： 尼龙
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：5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
有效期为 5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】手指固定器
【医疗器械备案凭证编号】
粤深械备 20190644 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 20190644 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07 月24 号
【网址】www.simplemedical.cn

www.simplemedical.cn
Simple Medical（Shenzhen）Limited
Instruction for Use
Thumb brace W1
Model:31901 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：Thumb brace W1
2) product model：31901
3) Product specification：F
4) Product Structure：
The product is mainly composed of a breathable and soft body,
supporting device and binding straps.
5 ) Operating principle
The product adopts lightweight design, easy to use and comfortable
to wear The large body and support device with special outline of
the product can comfortably provide maximum support for the
thumb and limit the movement of the thumb, and the large body
with soft fabric can provide comfortable wearing degree for
patients Helps relieve pain related to thumb joints and repetitive
stress.
6) Scope of application
Mild to moderate thumb joint sprains and strains, postoperative
healing and other soft tissue injuries to restore fixed support
Product features and performance description
1) Product features and storage conditions
【Product features】Breathable, comfortable, Light weight, max
support, Adjustable straps.
【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
STEP1: Loosen all the straps put the hands into the holder (fig a)
STEP 2:Tie the strap #1 through the lashing hole before tightening it
(fig b)
STEP 3: Tie the thumb strap #2 through the hole and fasten it (fig c)
STEP 4: Tie the strap #3(fig d).
Note: do not tie the band too tight, please adjust the tightness of the
band as needed
Maintenance:
Lining 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.
Basic product environment
1) Ambient temperature: -15 ~ 60℃
2) Relative humidity: 80%
Product material
1) Body material: spandex, nylon, polyester PU
2) Support sheet: polypropylene
3) Strap: nylon
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：5 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
Hand wash only
Protect from sunlight
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