Radiopaque bone cement for filling and stabilising vertebral bodies

OSTEOPAL® VEN Instructions for use 3 Working times 6 (Revision status: 2019-08)

ZH 使用说明书 7 加工时间 10 (修订状态：2019 年 08 月

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OSTEOPAL® VEN

Properties – CompositionOSTEOPAL® V is a radiopaque, low-viscosity, quick-setting bone cement for filling and stabilising vertebral bodies. It is obtained by mixing a polymer powder component with a liquid monomer component. Zirconium oxide has been added to the cement powder as an X-ray contrast medium.The sterile-filtrated monomer component is supplied in an amber glass ampoule and comes in a sterile blister pack.The polymer powder component is supplied in a double sterile packaging. The inner polyethylene sachet which contains the powder component is wrapped in an additional polyethylene sachet; both sachets were sterilized with ethylene oxide. The polyethylene sachets are contained in a non-sterile protective aluminium packaging.Copper complexes of chlorophylls and chlorophyllins (E141) has been used to obtain the green color of OSTEOPAL® V in order to ensure clear visibility of the cement at the operating site.After mixing, a low-viscosity dough is obtained which is filled into the vertebral bodies as a stabilisation medium and allowed to harden.

IndicationsOSTEOPAL® V is used for augmentation of vertebral bodies• for painful compression fractures of the vertebral body• for painful tumors in the vertebral body

(metastatic carcinomas or myelomas)• for symptomatic vertebral hemangiomasPercutaneous vertebroplasty is only a palliative treatment for stabilizing the vertebral bodies. It does not treat the underlying illness (osteoporosis, tumor-related illness).

ContraindicationsHemorrhagic diatheses and infections are absolute contraindications. Lesions of the vertebral body with epidural extension are relative contraindications because of the danger of spinal cord compression. OSTEOPAL® V must not be used in cases of known hyper-sensitivity to the constituents of the bone cement, nor during pregnancy or nursing.

Warning information – Side effectsPrior to using OSTEOPAL® V the surgeon should be familiar with its properties, handling and application. It is also recommended for surgeons to practice mixing, handling and application prior to the use. Precise knowledge is also required, if mixing systems and syringes are used for the application of the cement. The monomer liquid is highly volatile and flammable; accordingly suitable precautionary measures should be taken for the use in the operating room. The monomer is also a powerful lipid solvent and should not come into direct contact with the body. When working with the monomer or the cement, gloves must be worn to ensure adequate protection against the penetration of the monomer (methyl methacrylate) into the skin. PVP (three-layer polyethylene, ethylene-vinyl alcohol-copolymer, poIyethylene) and Viton/Butyl gloves have proved to provide good protection over an extended period. Putting on two pairs of gloves has also proved to offer adequate protection.The use of latex or polystyrene-butadiene gloves alone, however, must be avoided. Please request the confirmation of your glove supplier whether the respective gloves are suitable for the use with OSTEOPAL® V.

Composition OSTEOPAL® V 1x20

1 sachet of 26 g powder contains:

poly (methyl acrylate, methyl methacrylate) 14.2 g

zirconium dioxide 11.7 g

benzoyl peroxide 0.1 g

1 ampule of 10 ml liquid contains:

methyl methacrylate 9.2 g

N,N-dimethyl-p-toluidine 0.2 g

Other constituents In the powder: colourant E141In the liquid: colourant E141, hydroquinone

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The monomer vapors may irritate the respiratory tract and the eyes and possibly damage the liver. Skin irritations have been reported, which must be attributed to the contact with the monomer.Manufacturers of soft contact lenses recommend the removal of the lenses in the presence of harmful or irritating vapors. Since contact lenses are permeable to liquids and gases, they should not be worn in the operating room if methyl methacrylate is used.

Precautionary measures for applicationDirectly after implanting the bone cement into the vertebral body, the increase in pressure in the vertebral bodies can lead to a temporary drop in blood pressure. In rare cases, the hypotension may be accompanied by pulmonary embo-lism and cardiac arrest. These cardiovascular and respira-tory side effects, also known as implantation syndrome or bone cement syndrome, result from an influx of bone marrow constituents into the venous vascular system.If pulmonary, cardiovascular complications arise, moni-toring and – in some cases – even increasing the blood volume may be required. In cases of acute respiratory insufficiency, anesthesiological measures should be taken.In addition, paravertebral structures may be damaged by cement escaping. Complications such as spinal cord compression, intercostal neuralgia, cement escaping into the intervertebral space, perivertebral filling of veins and arteries (danger of embolism), infections and post-proce-dural pain are possible.To prevent cement escape and in order to detect unwanted occurrences in good time, application must be performed using imaging techniques (real-time display). In order to detect a vertebral extension, a phlebography must be performed before applying the cement. Immediate surgical intervention may also be necessary to counteract the described complications. Prior to surgery, a careful radio-logical investigation must be performed to assess possible risks (e.g. vertebral-body lesions, vascular supply of the vertebral body or edema). When treating hemangiomas, preoperative angiosclerosis through percutaneous applica-tion of alcohol may help prevent cement entering the vascular structures. Incomplete filling of the vertebral body with bone cement may result in an insufficient reduction in acute pain and reduced long-term stability of the treated vertebral body.

InteractionsNo known interactions.

IncompatibilitiesAqueous (e.g containing antibiotics) solutions must not be added to the bone cement since they considerably impair the mechanical properties of the cement.

DoseThe amount of bone cement required depends on the particular anatomical conditions. No information is avail-able on the maximum amount of bone cement that can be used and the maximum number of vertebral bodies to be treated by a vertebroplasty procedure. One or more units (sachet and ampoule) must always be mixed together.

Notes on applicationWhen applying OSTEOPAL® V, the requirements of current cement techniques must be observed in order to prevent unwanted side effects and to ensure stable, long-term fixa-tion of the bone cement in the vertebral body. Application must be performed with an instrument authorized for filling vetebral bodies, and the operator must be familiar with the use of this instrument.

PreparationA single dose is prepared by mixing the entire content of a powder sachet with one ampoule. In most cases, one or two portions suffice, although this depends on the particular surgical operation and the technique used. Before the beginning of the operation, at least one additional dose of OSTEOPAL® V should be readily available. Each dose is prepared separately. The following is required to prepare the bone cement: Sterile working surface, porcelain or stainless-steel bowls, sterile mixing spoons or porcelain or stainless-steel spat-ulas.The protective aluminium packaging, the outer non-sterile polyethylene sachet and the blister pack of the ampoule should be opened by an assistant in a way that maintains sterility. The sterile polyethylene sachet and the ampoule are placed under aseptic conditions on a sterile desk. Sterile conditions must be ensured when opening the poly-ethylene sachet and the ampoule.

ProcessingProcessing time and polymerization are heavily dependent on the temperature of the components and the ambient conditions. High temperatures accelerate hardening time, low temperatures prolong it. Viscosity increases as poly-merization progresses, i.e. as the processing phase progresses.The cement mixture is drawn into a syringe as soon as it is mixed, as it is then still low-viscosity and easy to inject. To prevent a vascular escape of cement, it should be applied when soft. OSTEOPAL® V can be injected into the vertebral body using a cement syringe authorized for percutaneous vertebroplasty which allows constant and controlled injec-tion. For instructions on using the cement syringe, users should refer to the manufacturer’s instructions. Intraverte-bral application must be supported by fluoroscopy (latero-lateral) with real-time display. In the event of paravertebral cement escape, cement injection must be stopped immedi-ately and can be continued after increasing the viscosity of the cement. If vertebral filling is insufficient, further contralateral access is possible. After augmentation, a mandrin should be inserted in the injection needle, to prevent any cement residue remaining in the soft tissues after the injection needle is removed. The processing times and their temperature dependency are shown in the table. These values apply when using CementoSet (Optimed GmbH, 76275 Ettlingen, Germany) with an injection cannula of diameter 3.2 mm. For other syringe systems, different processing methods may be used.Cannulas with a diameter less than 1.8 mm should not be used. The patient must be immobilized until the cement has completely hardened.

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StorageDo not store above 25°C.

Shelf life/SterilityThe expiration date is printed on the folded box, the protective aluminium packaging and the inner sachet. OSTEOPAL® V must not be used after the expiration date. The contents of unused but opened or damaged packs must be discarded and must not be resterilized. OSTEOPAL® V has been sterilized with ethylene oxide gas and must not be resterilized. The polymer powder must not be used if it exhibits yellow. Please see the date of produc-tion and shelf life information on label.

Disposal Single components of the bone cement, cured solid material as well as (uncleaned) packaging material must be disposed by following the regulations of the local authorities.

Registrant / Manufacturer name: Heraeus Medical GmbHRegistered office address: Philipp-Reis-Straße 8/13,61273 Wehrheim, GermanyManufacturing address: Philipp-Reis-Straße 8/13,61273 Wehrheim, GermanyTelephone: +49 (0) 6181.35-3399Fax: +49 (0) 6181.35-3366Website: www.heraeus-medical.com

After sale-service agent / Name of agent: LandMover Medical & Technology (Beijing) Co., Ltd.Address: Room 606, 607, Fifth F., Tower 3, 16# South 3rd Ring West Road, Fengtai District, Beijing, ChinaTel: +86 10 6750 6618Fax: +86 10 6750 6618 ext. 804

License number / Product technical requirement: 20143135901Date of preparation or revision of the manual: 2019-08

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OSTEOPAL® V特性 - 成分

OSTEOPAL®V是一种用于填充和稳定椎体的，不透辐射的快

凝骨水泥，呈低粘性。其制备方法为将一粉末状成分与一

种液单体成分相混合。二氧化锆已被作为X射线造影剂加入

该骨粉。

该经无菌过滤的单体成分供货时以琥珀玻璃安瓿装，外加

有无菌泡罩包装，其经环氧乙烷灭菌。

粉末状的聚合体成分以双层无菌包装的形式供应，即在一

个内层聚乙烯小袋中装粉末状成分，在其外再包一个聚乙

烯小袋，这两个小袋均已用环氧乙烷（EO）灭菌。在这两

个小袋外加有非无菌保护性铝包装。

叶绿素铜（E141）被用来使OSTEOPAL®V变成绿色，以使

该水泥在手术区域上清晰可见。

混合后，形成了一种面团状物质，其被作为稳定物质注入

椎体，然后固化。

适应症：

OSTEOPAL®V 适用于椎体的充填与稳定。

• 缓解和消除椎体压缩骨折的疼痛

• 缓解和消除椎体瘤（转移癌或骨髓瘤）的疼痛

• 症状性椎体血管瘤

经皮椎体成形术只是对稳定椎体的一种姑息治疗。它并不能

治疗潜在的疾病（例如骨质疏松症、肿瘤等相关疾病）。

禁忌症：

出血素质和感染是绝对禁忌证。硬膜外扩造成椎体损伤是

相对禁忌征，因为会有脊髓压迫症的危险。OSTEOPAL®V

不能用于已知对骨水泥成分过敏的病例中，在怀孕期或哺

乳期间禁用。

警示信息 – 副作用

在使用OSTEOPAL®V 之前，外科医生应熟悉其性质、处理

方法和应用。建议外科医生在使用之前，练习混合、处理

和施用。如果在施用骨水泥时使用混合系统和注射器，需

要了解详尽的有关知识。单体液体具有高度的挥发性和易

燃性，因此在手术室内应采用适当的预防措施。该单体液

体也是强脂溶剂，不应与人体直接接触。当处理单体液体

或水泥时，应戴上手套以充分地防止单体（甲基丙烯酸甲

酯）渗入皮肤。由三层聚乙烯，乙烯-乙烯醇共聚物，聚乙

烯和氟橡胶（Viton®）/丁基制成的手套经长时间的检验，

已被证明可提供充分的保护。戴两双手套也已被证明可提

供充分的保护。但必须避免仅戴乳胶或聚苯乙烯-丁二烯手

套。请要求您的手套供货商确认有关手套是否适用于用

OSTEOPAL®V。

单体汽可刺激呼吸道和眼睛，可能对肝造成伤害。曾已有

因与单体接触而引发的皮肤炎症的报导。

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成分 OSTEOPAL®V 1x20

每小袋中的 26 g 粉中含有：

丙烯酸甲酯-甲基丙烯酸甲酯聚合物 14.2 g

二氧化锆 11.7 g

过氧化苯甲酰 0.1 g

每安瓿瓶中的10 ml 液体中含有：

甲基丙烯酸甲酯 9.2 g

N，N-二甲基-对甲苯胺 0.2 g

其它成分在粉中：叶绿素铜(E141);

在液体中：叶绿素铜(E141)，对苯二酚

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软性隐形眼镜的生产厂家建议在有害或刺激性气体存在的

情况下去除镜片。因为液体和气体可渗透过隐形眼镜的镜

片，如使用甲基丙烯酸甲酯，不得在手术室内戴隐形眼镜。

使用的预防措施

将骨水泥注入椎体后，椎体内压力的上升会导致血压的临

时下降。在一些少见的病例中，有低血压伴随肺栓塞和心

跳骤停的情况出现。这些心血管和呼吸器官的副作用，也

是植入术或者骨水泥的并发症状，是骨髓成分流入静脉维

管系统引起的。

如果发生肺、心血管并发症，需要监控血量，有一些病例

中甚至可能需要增加血量。在急性呼吸功能不全的情况中，

应采取麻醉措施。此外，脊柱旁的结构可能会被溢出的骨

水泥损坏。可能会出现如下并发症：脊髓压迫症、肋间神

经痛、骨水泥溢出到椎间隙、椎骨周静脉和动脉填充

（栓塞的危险）、感染和手术后的疼痛。为了防止骨水泥

溢出，并且为了侦测不必要的事件，必须使用成像技术

（实时显示）进行监控。为了检测脊柱背伸，必须要在施

用骨水泥前进行静脉造影术。也有必要采用一些外科技术

来应对以上描述的并发症。手术之前，必须要仔细的进行

放射研究，来评测可能会出现的风险（例如椎体损伤、椎

体维管联结或水肿）。在治疗血管瘤时，经皮使用乙醇的

动脉硬化再次手术能够预防骨水泥进入血管结构。使用骨

水泥填充椎体，如果填充不完全，就不能完全缓解和消除

急性痛，并会减少治疗后的椎体的长期稳定性。

相互作用

无交互作用。

不相容性

勿将水溶液（例如含抗生素的）加入骨水泥，因为这些水

溶液会相当大地损害骨水泥的力学性质。

剂量

所需骨水泥的剂量取决于相应的解剖情况。没有所需骨水

泥最大量的信息，也没有需要通过椎体成形术治疗的椎体

的最大数量的信息。

施用

在使用OSTEOPAL®V 时，必须要观察所使用的骨水泥技

术，从而预防不必要的副作用，并确保骨水泥在椎体中的

稳定、长期的固定。操作时必须要遵守经认可的填充椎体

的说明书，操作者必须要熟悉使用说明书。

制备

将一袋粉的小袋中全部内容物与一个安瓿内的液体相混合

以制备一剂。使用剂量取决于相应手术和所采用的技术，

大多数情况下，一个或者两个剂量就足够了。在手术开始

前，必须准备至少一剂备用的OSTEOPAL®V。每一剂应单独

制备。

下列为制备骨水泥所需要的条件：

无菌工作台面、瓷或不锈钢碗，无菌搅拌勺、瓷或不锈钢

调药刀或一无菌真空混合系统。

应由助手以保持无菌的方法打开保护性铝包装、外层非无

菌聚乙烯小袋和安瓿的泡罩包装。无菌聚乙烯小袋和安瓿

瓶应在无菌条件下放置地无菌工作台上。并应保证在无菌

状态下打开聚乙烯小袋和安瓿瓶。

处理

处理时间和聚合作用取决于材料温度和室温。温度高会加

速固化时间，温度低则会延长固化时间。粘度随着聚合作

用的进行而增加，也就是说随着处理过程的进行而增加。

一旦混合好，就将骨水泥倒入注射器中，因为这时候粘度

还比较低，能够很容易的进行注射。为了预防骨水泥溢出

到血管中，应该在它变柔软的时候施用。可以使用经认可

的可用于经皮椎体成形术的骨水泥注射器，将OSTEOPAL®V

注射进椎体，这种注射器可以进行持续并可控制的注射。

使用者应该参考骨水泥注射器生产厂商的使用说明进行操

作。脊柱内施用必须要有实时显示的X射线检查（侧后方）

进行监控。若出现脊柱旁骨水泥溢出，必须马上停止骨水

泥的注射，等到粘度增加一些以后才可以继续注射。如果

不能进行脊柱填充，那么可以从对侧进行填充。注射之后，

将一个 细探针 插入注射管中，从而避免将注射管移走后，

会有骨水泥残留在软组织中。处理时间与温度的相关性请

见下表。这些值是在使用Cemento-Set (Optimed GmbH,

76275 Ettlingen, Germany)，直径3.2mm的注射管时得到

的。对于其他的注射器，可能会使用不同的处理方法。不

能使用直径小于1.8mm的注射管。必须将病人固定，直到

骨水泥完全固化。

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储存

勿储存在高于25摄氏度的温度下。

储存期/无菌状态

该产品有效期三年。过期日期被印在折叠的盒、保护性铝

包装和内层小袋上。该产品有效期三年。过期

后，OSTEOPAL®V不能使用。未使用过的、但已打开或损坏

的包装必须丢弃，不能再对其灭菌。聚合粉末如已呈黄色，

不能再使用。 生产日期及有效期请见标签。

废弃处理

必须根据当地的规范性规定废弃处理骨水泥各组分、硬化

骨水泥以及(未清洁的)包装材料。

注册人 / 生产企业名称：Heraeus Medical GmbH注册人 / 企业中文名称：贺利氏医疗有限公司住所：Philipp-Reis-Straße 8/13, 61273 Wehrheim, Germany生产地址：Philipp-Reis-Straße 8/13, 61273 Wehrheim, Germany电话：+49 (0) 6181.35-3399传真：+49 (0) 6181.35-3366网址：www.heraeus-medical.com

售后服务单位 / 代理人名称： 雷德睦华医药科技（北京）有限公司住所：北京市丰台区南三环西路16号3号楼5层606、607电话：010-6750 6618传真：010-6750 6618 转 804医疗器械注册证编号 / 产品技术要求编号： 国械注进20143135901说明书的编制或修订日期：2019-08

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SYMBOLS / 符号

Manufacturer / 生产厂商

Sterilized using aseptic processing techniques / 无菌处理

Sterilized using ethylene oxide / 环氧乙烷灭菌

Consult instructions for use / 参考使用说明书

Keep away from sunlight / 避免光照

Keep dry / 保持干燥25 °C77 °F Do not store above 25 °C (77 °F) /

请勿储存于25摄氏度(77华氏度)以上的环境

Do not re-use / 请勿二次使用

Do not resterilize / 请勿二次灭菌

Catalogue number / 产品编号

Use by date / 有效期

Batch code / 批号

Flammable liquid – Flashpoint 10 °C / 易燃液体-闪点10摄氏度

Causes skin irritation / 刺激皮肤

Do not use if the product sterile barrier system or its packaging is compromised / 如果产品无菌屏障系统或其包装已受损，请不要使用

01230123OSTEOPAL® is a trademark of Heraeus Medical GmbH.

Heraeus Medical GmbHPhilipp-Reis-Straße 8/13 61273 Wehrheim, Germanywww.heraeus-medical.com

66055104