Merit Medical HeartSpan Transseptal Neddle China 取扱説明書
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- 取扱説明書
Read instructions for use in its entirety prior to use.
Single use only disposable medical device.
Rx Only: Caution: Federal (U.S.A.) law restricts
this device to sale by or on the order of a
physician.
Device Description
The transseptal needle kit consists of an outer
needle cannula and an inner stylet. The needle
is comprised of exible thin walled tubing with
an ergonomic hub and stopcock attached to
the proximal end. The stylet consists of a solid
wire that when inserted in the needle protrudes
beyond the distal tip of the cannula.
Indications for Use
The transseptal needle is used in conjunction
with a transseptal catheter and/or introducer to
create the puncture in the atrial septum to allow
left heart catheterization procedure to occur
through the right atrium.
Contraindications
• Left atrial thrombus or tumor
• Dilated aortic root
• Continual anticoagulation
• Inability to lie at
• Substantial deformity of the spine or chest
• Marked atrial enlargement
• Distorted anatomy due to congenital heart
disease
• Previous intra-septum patch
Warnings
• For single use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resteriliza-
tion may compromise the structural integrity
of the device and/or lead to device failure
which in turn may result in patient injury,
illness or death. This single-use product is not
designed or validated to be reused. Reuse may
cause a risk of cross-contamination, aect the
measurement accuracy, system performance,
or cause a malfunction as a result of the prod-
uct being physically damaged due to cleaning,
disinfection, re-sterilization, or reuse.
• Only those physicians who specialize in the
practice of invasive cardiology techniques
should use this device. The device should be
restricted for use by those specialists trained
to perform transseptal procedures.
• Maintain continuous pressure monitoring
and repeated biplane uoroscopy during
positioning.
• Caution should be used in patients with small
left atrium, to avoid left atrial wall puncture.
• The transseptal needle should never be
advanced until the catheter is positioned
correctly on the atrial septum.
404854004ZHP_001 ID 2023-06-30
Manufacturer:
Merit Medical System, Inc.
1600 West Merit Parkway South Jordan, Utah 84095 U.S.A.
1-801-253-1600 U.S.A
Customer Service 1-800-356-3748
www.merit.com
Transseptal Needle and Stylet Set
Directions for Use
• Always ensure that the transseptal needle
has clearly entered the left atrial cavity by
conrming distinct left atrial pressure and u-
oroscopy of the needle tip before advancing
the dilator, sheath or catheter.
• Do not remove a dilator, sheath or catheter
that has been inadvertently advanced into the
pericardial space until the patient is in surgery.
• Do not reuse this device. The device must
be discarded after one use using acceptable
medical practices and applicable local, state
and federal laws and regulations.
• Follow instructions accompanying the trans-
septal introducers.
Precautions
• Store in a cool, dark and dry place.
• Inspect all components prior to use.
• If resistance is met while advancing or with-
drawing the introducer or guidewire, uoros-
copy should be used to determine the cause.
• Prior to use, ensure the appropriate catheter is
being used with the transseptal needle.
Adverse Events
In addition to the complications associated with
any cardiac catheterization, the following could
occur during a transseptal catheterization:
• Inferior vena cava puncture
• Aorta puncture
• Atrial free wall puncture
• Coronary sinus puncture
• Arterial embolism from thrombus at the
puncture site
• Tamponade
• Residual atrial septal defects
• Atrial arrhythmia
Directions for Use
1. To determine the size and location of the left
atrial septum, it may be helpful to perform
right side angiography.
2. Thoroughly ush the transseptal needle.
3. Inspect all components prior to use for integ-
rity and appropriateness for the particular
procedure.
4. The transseptal needle/stylet set is advanced
through the transseptal catheter and/or intro-
ducer until the tip of the needle is just within
the catheter. Note: Ensure the transseptal
needle is free to twist and/or rotate without
resistance, as it is advanced to this position.
5. Retract the stylet prior to puncturing the inter-
atrial septum.
6. The tip of the transseptal needle is positioned
against the interatrial septum.
7. The transseptal needle is advanced through
the septum into the left atrium once the cor-
rect location is conrmed using uoroscopy
(preferably biplane).
8. The successful puncture into the left atrium is
conrmed by observing a left atrial pressure
tracing. If an incorrect pressure tracing is
observed, a small amount of contrast media is
injected to identify the positioning.
9. The transseptal catheter is advanced over the
transseptal needle into the left atrium.
10.
The transseptal needle is slowly removed.
Shelf Life: 3 years.
Contents non-pyrogenic
and sterilized using ethylene
oxide
Do not resterilize
Single use only / Do not
reuse
Manufacturer
Manufacturing date
LOTLot number
Expiration date
Number of
Do not use if packaging is
damaged!
REF Catalog number
Caution, read intructions for
use prior to use
Product number
Proximal gage
Distal gage
Store in a cool, dark and dry
place
Transseptal Needles
使用前请完整阅读使用说明。
仅供单个患者使用的一次性医疗器械。
警告：警告：美国联邦法律要求本器械仅凭医嘱销
售。
产品描述产品描述
房间隔穿刺针由针套，座/手柄，旋塞阀，管芯
针和管芯针帽组成。材料：304不锈钢，聚碳
酸酯和高密度聚乙烯。
适用范围适用范围
房间隔穿刺针用于在心房间隔上造成原发性穿
孔，以使导管鞘和/或导管从心脏右侧穿过间隔
到达心脏左侧。
禁忌症禁忌症
• 左心房血栓或肿瘤
• 主动脉根部扩张
• 持续抗凝治疗
• 患者不能平躺
• 脊柱或胸廓严重畸形
• 心房显著增大
• 先天性心脏病导致的扭曲性解剖结构
• 术后间隔修补
警告警告
• 仅限一次性使用。不能重复使用、再加工或
灭菌。重复使用、再加工或重复灭菌可能会
危害器械的结构完整性，导致器械运转不
良，对患者造成伤害、致病或死亡。该一次
性使用产品未设计或验证用于重复使用。重
复使用可能会导致交叉感染、影响测量准确
性、器械性能或因清洁、灭菌、重复灭菌或
重复使用导致物理损坏而造成故障的风险。
• 只有那些专门从事有创心血管技术操作的医
生才能使用此器械。该器械仅限于训练有素
的专家进行房间隔穿刺术。
• 定位时应持续监测压力，并重复进行双平面X
射线透视。
• 用于左心房小的患者时应小心，以避免刺穿
左心房壁。
• 导管在房间隔正确定位后，才能向前推进房
间隔穿刺针。
• 推进扩张器、鞘管或导管前，请务必通过监
测左心房压力和X射线透视确保房间隔穿刺针
明确进入左心房腔内。
• 请勿取出意外进入心包腔的扩张器、鞘管或
导管，除非对患者进行外科手术。
• 请勿重复使用此装置。必须根据可接受的医
疗规范和适用的本地、州和联邦法律和法规
对经一次性使用的器械进行处置。
• 请遵照房间隔穿刺鞘随附的说明书。
注意事项注意事项
• 产品应贮存在通气良好，无腐蚀性气体的室
内。
• 使用前请检查所有组件。
房间隔穿刺针房间隔穿刺针
使用说明使用说明
• 如果在推进或退出鞘或导丝时遇到阻力，应
当进行X射线透视以确定原因。
• 使用房间隔穿刺针前，请确保使用恰当的鞘
管。
不良事件不良事件
除了与任何心导管插入术相关的并发症外，
在室间隔穿刺插入导管术中，可能会发生以下
情况：
• 穿破下腔静脉
• 穿破主动脉
• 穿破心房游离壁
• 穿破冠状窦
• 穿刺部位血栓造成动脉栓塞
• 心包填塞
• 遗留房间隔缺损
• 房性心律失常
使用说明使用说明
1. 进行右侧血管造影可能会有助于测量左心房
间隔的大小和位置。
2. 彻底冲洗房间隔穿刺针。
3. 使用前检查所有部件的完整性和进行是否适
用于特定操作。
4. 将房间隔穿刺针/管芯针推进房间隔穿刺鞘，
直至针尖刚好到达鞘管前端。注意:请确保房
间隔穿刺针在推进到此位置时可以自由扭曲
和/或无阻力旋转。
5. 房间隔穿刺前缩回管芯针。
6. 调整房间隔穿刺针尖端正对房间隔。
7. 一旦使用X射线透视（最好为双平面）确认正
确定位后，推进房间隔穿刺针穿刺房间隔进
入左心房。
8. 通过观察左心房压力监测值确认成功穿刺
进入左心房。如果观察到不正确的压力监测
值，将注射少量造影剂，以确定位置。
9. 沿房间隔穿刺针推送房间隔穿刺导鞘进入左
心房。
10. 缓慢退出房间隔穿刺针。
结构及组成
房间隔穿刺针由套管针，座/手柄，旋塞阀，
管芯针和管芯针帽组成。材料：304不锈
钢，聚碳酸酯和高密度聚乙烯。环氧乙烷灭
菌，一次性使用，货架有效期三年。
生产日期和失效日期：见产品标签。
有效期：3年
注册证编号：国械注进20193031836
产品技术要求编号： 国械注进20193031836
中国境内代理人及售后服务单位名称：麦瑞通
医疗器械（北京）有限公司
中国境内代理人及售后服务单位住所：北京
市朝阳区东大桥路9号楼2单元801室内B01
、B02及B03单元
中国境内代理人及售后服务单位电话：
010‐85610788
中国境内代理人及售后服务单位传真：
010‐85616981
注册人及生产企业名称：美国麦瑞通医疗设备
有限公司 MERIT MEDICAL SYSTEMS, INC.
注册人及生产企业住所：1600 West Merit
Pkwy South Jordan, UT 84095
生产地址：14646 Kirby Drive Houston,
Texas, 77047 USA；Avenida Sor Juana Inés
de la Cruz 19970 interior B, Edificio 2 Parque
Industrial Frontera Tijuana, Baja California
C.P. 22630 Mexico;
注册人及生产企业联系方式：1-801-253-1600
说明书编制或修订日期： 2023年7月
型号规格：
FND-019-00 FND-019-01 FND-019-02
FND-019-03 FND-019-04 FND-019-05
FND-019-06
不含致热原并经环氧乙烷灭菌
请勿重复灭菌
仅限一次性使用/请勿重复
使用
制造商
制造日期
LOT批号
失效日期
数量
如果包装打开或损坏则禁止
使用
REF 订购编号
警告，使用前请阅读说明书
产品编号
近端
远端
产品应贮存在通气良好，无
腐蚀性气体的室内
Transseptal Needles
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Merit Medical HeartSpan Transseptal Neddle China 取扱説明書
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