【产品名称】导光凝胶

【型号规格】20g、25g、80g、100g、120g、150g、200g、240g、250g、500g、1000g、2500g。

【产品性能结构】由卡波姆、甘油、三乙醇胺、丙二醇、山梨酸钾、纯化水组成。产品不含有发挥药理学、免疫学或者代谢作用的成分，不包含附录所列成分。非无菌产品。不包含《第一类医疗器械产品目录》附录所列成分。

【适用范围】用于光子治疗过程中隔热和导光，与光子治疗设备配合使用。

【使用方法】光子治疗前在治疗部位涂抹，约2～3毫米厚度。大面积使用导光凝胶可能会使胶体温度升高，宜将整个治疗区域分成多个小块（每个小块直径约5厘米），涂好导光凝胶后应立即开始治疗。

【禁忌症】对本品过敏者禁用，高过敏体质者慎用。

【注意事项】

1、请将本品放在儿童不能接触的地方。

2、勿涂于破损皮肤部位。

3、使用中若有轻微不适或偶有皮肤表皮发红，停用即可自行恢复；严重过敏者请就医处理。

4、瓶底如有少量沉淀为正常现象，不影响使用。

【储存条件】室温储存，打开后请尽快使用。

【有效期】二年。

【备案人名称】山东科诺德生物医药科技有限公司

【备案人住所】山东省泰安高新区南天门大街中段高端人才基地

【售后服务机构】山东科诺德生物医药科技有限公司

【医疗器械备案编号】鲁泰械备20260001

【生产备案编号】鲁枣食药监械生产备20190005号

【产品技术要求编号】鲁泰械备20260001

其它详见说明书。

Light Guide Gel

Product Specifications

20 g, 25 g, 80 g, 100 g, 120 g, 150 g, 200 g, 240 g, 250 g, 500 g, 1000 g, 2500 g

Product Performance and Composition

Composed of carbomer, glycerin, triethanolamine, propylene glycol, potassium sorbate and purified water. The product contains no ingredients exerting pharmacological, immunological or metabolic effects, and does not include ingredients listed in the appendix. Non-sterile product. Free of ingredients specified in the appendix of the Catalogue of Class I Medical Devices.

Intended Use

For heat insulation and light conduction during photon therapy, to be used together with photon therapy equipment.

Instructions for Use

Apply a layer of approximately 2–3 mm thickness on the treatment area prior to photon therapy. Extensive application of light conductive gel may lead to temperature rise of the gel. It is recommended to divide the whole treatment area into multiple small sections (about 5 cm in diameter for each section). Start treatment immediately after applying the gel.

Contraindications

Forbidden for use on patients allergic to this product. Use with caution for highly allergic individuals.

Precautions

1.Keep out of reach of children.

2.Do not apply onto broken skin.

3.Mild discomfort or occasional epidermal redness may occur during use; symptoms will resolve spontaneously after discontinuation. Seek medical treatment in case of severe allergy.

4.A small amount of sediment at the bottom of the container is normal and does not affect use.

Storage Conditions

Store at room temperature. Use promptly after opening.

Filing Party

Shandong Kenuode Biomedical Technology Co., Ltd.

Filing Party Address

High-end Talent Base, Middle Section of Nantianmen Street, Tai’an High-tech Zone, Shandong Province

Shelf Life

2 years

After-sales Service Provider

Shandong Kenuode Biomedical Technology Co., Ltd.

Medical Device Filing Number

Lu Tai Medical Device Filing 20260001

Manufacturing Filing Number

Lu Zao Food and Drug Administration Medical Device Manufacturing Filing 20190005

Product Technical Requirement Number

Lu Tai Medical Device Filing 20260001

For further details, please refer to the instructions for use.