K-TEK KTEK9000 User manual

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
KTEK Curve Spine Frame:
KTEK9000
Crank Handle:
KTEK9010
Secure-Lok™Strap Connector:
KTEK9030
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 1
KTEK Curve Spine Frame
Instructions for Use
ENGLISH

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 2
Prior to using this or any other type of medical equipment with
a patient, it is recommended that you read the Instructions for
Use and familiarize yourself with the product.
• Read and understand all warnings in this manual and on the device itself prior to
use with a patient.
• The symbol is intended to alert the user to important procedures or safety
instructions regarding the use of this device.
• The symbol on the labels is intended to show when the IFU should be refer-
enced for use.
• The techniques detailed in this manual are only manufacturer’s suggestions. The
nal responsibility for patient care with respect to this device remains with the
attending physician.
• Device function should be checked prior to each usage.
• This device should only be operated by trained personnel.
• All modications, upgrades, or repairs must be performed by an authorized spe-
cialist.
• Any serious incident that has occurred in relation to the device should be report-
ed to the manufacturer and the national competent authority where the user is
located.
NEVER EXCEED THE WEIGHT CAPACITY AND LOAD DISTRIB-
UTON OF THE OPERATING ROOM TABLE

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 3
1 Instructions for Use:
1.1 Indication for Use:
The KTEK Curve spine frame provides maximum lordosis in a variety of surgical spine
procedures including, but not limited to Laminectomy, Decompression, Disc Surgery and
Microdiscectomy surgery. These devices are capable of being used with a broad patient
population as deemed appropriate by the caregiver or institution.
1.2 Intended Use:
The KTEK Curve spine frame is designed to position and support the patient’s spine in a
variety of surgical procedures including, but not limited to Laminectomy, Decompression,
Disc Surgery and Microdiscectomy surgery. These devices are intended to be used by
healthcare professionals within the Operating Room setting.
1.3 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and/or Healthcare profession-
als involved in the intended procedure utilizing the device. Not intended for Lay persons.
Intended Populations: This device is intended to be used with patients that do not
exceed the weight in the safe working load eld specied in the product specication
section 3.2.
1.4 Residual Risk:
This product complies with relevant performance, safety standards. However, device
harm from misuse, device damage, function or mechanical hazards cannot be complete-
ly excluded. User is responsible to ensure device is securely attached and will operate
in a safe manner.
2 Safety Considerations:
2.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE.
2.2 Equipment Misuse:
Do not use the product if package is damaged or unintentionally opened before use. All
modications, upgrades, or repairs must be performed by an authorized specialist.
2.3 Safe Disposal:
Customers should adhere to all federal, state, regional, and/or local laws and regulations
as it pertains to the safe disposal of medical devices and accessories.
If in doubt, the user of the device shall rst contact Kyra Medical Technical Support for
guidance on safe disposal protocols.

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 4
2.4 Symbols:
Symbol Used Description Reference
Indicates the device is a medical device MDR 2017/745
Indicates the medical device manufacturer EN ISO 15223-1
Indicates the manufacturer’s serial number EN ISO 15223-1
Indicates the medical device Global Trade Item
Number
21 CFR 830
MDR 2017/745
Indicates the manufacturer’s lot code EN ISO 15223-1
Indicates the date when the medical device was
manufactured EN ISO 15223-1
Indicates the manufacturer’s catalogue number EN ISO 15223-1
Indicates the need for the user to consult the instruc-
tions for use for important cautionary information
such as warnings and precautions.
EN ISO 15223-1
Indicates the device do not contain natural rubber or
dry natural rubber latex EN ISO 15223-1
Indicates the authorized representative in the
European Community EN ISO 15223-1
Indicates the authorized representative in
Switzerland EN ISO 15223-1
Indicates the authorized representative in the
United Kingdom EN ISO 15223-1
Indicates the Medical Device complies to REGULA-
TION UK MDR 2002 UK MDR 2002
Indicates the Medical Device complies to REGULA-
TION (EU) 2017/745 MDR 2017/745
Indicates a Warning IEC 60601-1
Indicates the need for the user to consult the instruc-
tion for use EN ISO 15223-1

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 5
3 System:
3.1SystemComponetsIdentication:
1. Armboard Base
2. Armboard Pad
3. Rotation Release Handle
4. Side Rail Clamp Attachment
5. Rail Release Lever
6. Medial/Lateral Slide Buttons
Mechanical
Specications Description
Product Dimensions 30" x 17.5" x 10" (L x W x H) approx.
76.2 cm x 44.4 cm x 25.4 cm
Material Stainless Steel, Aluminum, Carbon Steel, Delrin, and
Polycarbonate
Safe Working Load
on the Device Do not exceed 600 lbs. (272 kg) patient weight
Overall Weight of
Device 24.4 lbs. (11 kg)
StorageSpecica-
tions Description
Storage Temperature -20ᵒ F to 140ᵒ F (-29ᵒ C to +60ᵒ C)
Storage Relative
Humidity Range 15% to 85%
3.2ProductSpecications:

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 6
3.3 System Setup and Use:
1. Center the KTEK Curve on the OR table or onto spine rail table connection.
2. Place Secure-Lok strap around the table rail, under and through the cleat and secure
the strap hole into the stud. Repeat for all 4 straps.
3. While pressing the button, slide the pad medially/laterally to provide patient support
and provide space for the abdomen. Fit disposables as directed on its packaging.
Operating Temperature This device is intended to be used in a controlled Op-
erating Room environment.
Operating Relative
Humidity Range
Compatibility
Specications Description
Compatible with:
• Curve Crank Handle KTEK9010
• Curve Cart KTEK1100
• Secure-Lok™ Strap Connector KTEK9030
• Curve Spine Replacement Pads (Pair) KTEK6450-P
Operating Room Table
Compatibility
Compatible with the following surgical table rail styles:
US, UK, EU, DEN, JP. Frame is compatible with rails
attachments of the OSI “Jackson” style tables and the
Allen® Advance table and Flex frame.

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 7
4. Ensure the leafs are captured under the lower side edge of the frame.
3.4 Positioning the Patient:
Position the patient onto the operating room table according to the requirements of the
surgeon and facility protocol.
1. Connect the Crank Handle. Turn Counter-clockwise to curve the pads. Turn Clock-
wise to atten the pads.
3.5 Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as necessary by
using a plastic scraper to remove the label. Use an alcohol wipe to remove any adhe-
sive residue.
Contact Kyra Medical, Inc., if you need to repair or replace the device contact us using
the information from the contact details section.
3.6 Cleaning and Disinfection:
WARNING:
• After each use, clean the device as directed in this instruction for use.
• Do not submerge the device in liquid. Equipment damage can occur.
• Use caution in areas where liquid can get into the mechanism.
• Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
• Make sure that the device is dry before you store it or use it again.
Wipes:
• Wipes may contain up to 2% sodium hypochlorite.
• Wipes may contain benzalkonium chloride (< or = 0.6% conc.) and didecyl dimethyl
ammonium chloride (up to 0.6% conc.)

INSTRUCTIONS FOR USE
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 8
• Wipes may contain benzalkonium chloride (up to 0.6% conc.), didecyl dimethyl
ammonium chloride (up to 0.6% conc.) and may also contain polyhexamethylene
biguanide (up to 0.6% conc.).
Sprays:
• Sprays may contain up to 2% sodium hypochlorite.
• Sprays may contain up to .2% benzalkonium chloride and up to 0.2% didecyl
dimethyl ammonium chloride (quaternary ammonium chloride solution (QACs) and
may also contain polyhexamethylene biguanide (up to 0.6% conc.).
• Sprays may contain up to 2% hydrogen peroxide.
Read the cleaning product’s directions and follow the instructions on the label. Use cau-
tion in areas where uid migration may occur:
Wipe device with a clean, dry cloth. Make certain the product is dry prior to reinstalling
to avoid damage.
CAUTION: Damage may result if product is cleaned with caustic chemicals or harsh
abrasives
ATTENTION: If any KTEK product is damaged or appears to be functioning abnormally,
discontinue use and contact KYRA Customer Service at 1-508-936-3550.
4 Compliance with Medical Device Regulations:
This product is a non-invasive, Class I Medical Device and system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device Regulations
(REGULATION (EU) 2017/745).
4.1 EC Authorized Representative:
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
4.2 Manufacturing Information:
Kyra Medical, Inc.
102 Otis St
Northborough, MA 01532 USA
888-611-KYRA (North America)
508-936-3550 (International)
4.3 UK Authorized Representative:
Emergo Consulting (UK) Limited
c/o Cr360 - UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom
4.4 EU Importer:
Kyra Medical Europe Limited
Ofce 2, 12A Lower Main St
Lucan Dublin
K78X5P8
Ireland
4.5 CH Authorized Representative:
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
KTEK Curve Spine Frame:
KTEK9000
Crank Handle:
KTEK9010
Secure-Lok™Strap Connector:
KTEK9030
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 9
KTEK Curve Spine Frame
使用须知
CHINESE

IFU 03-0235 REV J©2023 Kyra Medical, Inc. 10
用说明
在与患者一起使用此或任何其他类型的医疗设备之前，建议您阅
读 《使用说明》， 并熟悉产品。
永远不要超过手术操作台规定的最大承载重量和重量分配
• 在与患者一起使用之前，阅读并理解本手册和设备本身中的所有注意事
项。
•  该符号旨在提醒用户有关使用此设备的重要程序或安全说明。
• 标签上的符号旨在显示何时应引用IFU供使用。
• 本手册中详述的技术仅是制造商的建议。与使用此设备有关的患者护理
的最终责任仍由主治医生承担。
• 每次使用前应检查设备功能。
• 此设备仅应由训练有素的人员操作。
• 所有修改、升级或维修都必须由授权专家执行。
• 任何与设备有关的严重事故都应报告给制造商和用户所在的国家主管
部门。

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用说明
1 使用说明:
1.1 适用范围:
KTEK曲线脊柱框架在各种脊柱外科手术中提供最大的脊柱前凸，包括但不限于椎板切除
术、减压术、椎间盘手术和微型椎间盘手术。这些装置能够用于护理人员或机构认为合适的
广大患者群体。
1.2 使用范围:
KTEKCurve脊柱框架被设计为在各种手术过程中定位和支持病人的脊柱，包括但不限于
椎板切除术、减压术、椎间盘手术和显微椎板切除术。这些设备的目的是让医护人员在手术
室环境中使用
1.3 操作者和患者:
操作人员： 外科医生、护士、医生、家庭医生和/或参与使用该设备的医疗过程的专业人员。
不适合非专业人士。
患者人群： 使用本设备的患者体重不可超过产品规格第 3.2 节中指定的安全工作负载重
量。
1.4 可能风险:
本设备符合相关的性能、安全标准。但是不能完全排除设备误用、设备损坏、功能或机械损
坏造成的伤害。用户有责任确保设备被安全地连接，并以安全的方式操作。
2 安全考虑:
2.1 安全危险符号通知:
如果产品显示可见损坏，请不要使用。
2.2 设备误用提示:
如果包装损坏或在使用前无意打开，请不要使用该产品。所有修改、升级或维修都必须由授
权专家执行。
2.3 安全 销毁提示:
客户应遵守所有联邦、州、地区和/或地方法律和法规，因为它涉及医疗器械和配件的安全
销毁和处置。
如有疑问，设备用户应首先联系KYRA医疗技术支持部，以获得安全处置协议方面的指导。

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用说明
使用符号 描述 参考
表示设备是医疗设备 MDR 2017/745
表示医疗器械制造商 EN ISO 15223-1
指示制造商的序列号 EN ISO 15223-1
指示医疗器械全球贸易项目编号 21 CFR 830
MDR 2017/745
指示制造商的批号代码 EN ISO 15223-1
指示制造医疗器械的日期 EN ISO 15223-1
表示制造商的目录编号 EN ISO 15223-1
表示用户需要查阅说明，以获取重要的警告信息，如警
告和预防措施。 EN ISO 15223-1
表示设备不含天然橡胶或干天然橡胶乳胶 EN ISO 15223-1
表示在欧洲共同体的授权代表 EN ISO 15223-1
表示在瑞士的授权代表 EN ISO 15223-1
表示在英国的授权代表 EN ISO 15223-1
表示该医疗器械符合英国MDR2002法规 UK MDR 2002
表示医疗设备符合2017/745年法规（EU） MDR 2017/745
指示警告 IEC 60601-1
表示用户需要咨询使用说明 EN ISO 15223-1
2.4 符号:

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用说明
3 系统:
3.1 系统 部件名称:
1. 凝胶垫
2. 碳纤维叶子
3. 曲柄连接器
4. Secure-Lok带子
5. 底部手柄
6. 内侧/外侧滑动按钮
机械规格 描述
产品尺寸 30"x17.5"x10"(LxWxH)approx.
76.2cmx44.4cmx25.4cm
材料 不锈钢、铝、碳钢、Delrin和聚碳酸酯。
设备上的安全工作负载 不要超过600磅。（272公斤）患者体重
设备的整体重量 24.4 lbs. (11 kg)
3.2 产品规格:

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用说明
存储规则 31.4 lbs. (14.24 kg)
存储温度 -20oF至140oF（-29oC至+60oC）
存储相对湿度范围 15%至85%
操作温度 Thisdeviceisintendedtobeusedinacon-
trolledOperatingRoomenvironment.
操作相对湿度范围
兼容性 描述
可兼容：
• Curve Crank Handle KTEK9010
• Curve Cart KTEK1100
• Secure-Lok™ Strap Connector KTEK9030
• Curve Spine Replacement Pads (Pair)
KTEK6450-P
兼容手术台
KTEKCurve脊柱框架与下列手术台的导轨样式兼
容。美国、英国、欧盟、丹麦、日本。KTEKCurve脊柱
框架与OSI"Jackson"式手术台和Allen®Advance
手术台和Flex框架的导轨附件兼容。
3.3 系统设置和使用:
1. 将KTEKCurve放在手术台的中心，或放在脊柱轨道台的连接处。
2. 将Secure-Lok背带绕过桌子导轨，放在夹板下面并穿过夹板，将背带孔固定在螺柱上。
对所有4条带子进行重复操作。


IFU 03-0235 REV J©2023 Kyra Medical, Inc. 15
3. 在按下按钮的同时，向内侧/侧面滑动垫子，为病人提供支撑并为腹部提供空间。按照其
包装上的指示安装一次性用品。
4. 确保叶片被夹在框架的下侧边缘之下。
3.4 患者定位:
根据外科医生的要求和设施协议，将病人放在手术室的桌子上。
连接曲柄。逆时针旋转，使垫子弯曲。顺时针旋转，使垫子变平。

3.5 设备维护:
确保所有标签都已安装并可以读取。根据需要更换标签，使用塑料刮刀去除标签。使用酒精
擦除任何粘合剂残留物。
如果您需要维修或更换设备，请联系KYRA医疗公司，请使用联系人详细信息部分的信息与
我们联系。
3.6 清洁和消毒:
警告:
• 每次使用后，按照本指令中的指示清洁设备以供使用。
• 不要将设备浸入液体中以免发生设备损坏。
• 在液体可以进入设备的区域内请谨慎使用。
• 不要使用漂白剂或含有漂白剂的产品来清洁设备以免造成伤害或设备损坏。
• 在存储设备或再次使用之前，请确保设备干燥。
用说明

IFU 03-0235 REV J©2023 Kyra Medical, Inc. 16
擦拭
• 湿巾主要含有不超过2%的次氯酸钠。
• 湿巾可能含有氯化苯（低于或等于0.6%浓度）和二甲基氯化铵（不超过0.6%浓度）
• 湿巾主要含有氯化苯（不超过0.6%浓度）、二甲基氯化铵（不超过0.6%浓度），也可能含
有聚乙酰二甲苯（不超过0.6%浓度）。
喷雾:
• 喷雾剂主要含有不超过2%的次氯酸钠。
• 喷雾剂可能含有不超过0.2%的氯化苯和不超过0.2%的二甲基氯化铵（四元氯化铵溶
液（QAC），也可能含有聚乙酰二甲苯（不超过0.6%浓度）。
• 喷雾剂可能含有不超过2%的过氧化氢。
阅读清洁产品的说明，并按照标签上的说明操作。在可能有液体的区域内要小心：
用干净干燥的布擦拭设备。在重新安装之前确保产品干燥，以避免损坏。
警告：如果产品用腐蚀性化学品或苛刻的磨料清洗，可能会造成损坏
注意：如果发现任何KTEK产品损坏或功能异常，请停止使用并拨打1-508-936-3550联系
KYRA客户服务部
4 遵从医疗设备法规
用说明
此product是一种非侵入性的I类医疗设备，系统根据《医疗器械条例（监管
（EU）2017/745）附件八第1规则》进行CE标记。
4.1 欧共体授权的代表:
Emergo Europe
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
4.2 制造商信息:
Kyra Medical, Inc.
102 Otis St
Northborough, MA 01532 USA
888-611-KYRA (North America)
508-936-3550 (International)
4.3 英国授权代表:
Emergo Consulting (UK) Limited
c/o Cr360 - UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom
4.4 欧盟进口商:
Kyra Medical Europe Limited
Ofce 2, 12A Lower Main St
Lucan Dublin
K78X5P8
Ireland
4.5 CH 授权代表：
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
KTEK Curve Spine Frame:
KTEK9000
Crank Handle:
KTEK9010
Secure-Lok™Strap Connector:
KTEK9030
IFU 03-0235 REV J©2023 Kyra Medical, Inc. 17
KTEK Curve Spine Frame
Brugsanvisning
DANISH

IFU 03-0235 REV J©2023 Kyra Medical, Inc. 18
BRUGSANVISNING
Før du bruger dette eller en anden form for medicinsk udstyr på
en patient, anbefales det, at du læser brugsanvisningen (IFU)
og bliver fortrolig med produktet.
MÅ ALDRIG OVERSTIGE VÆGTKAPACITETEN OG FORDEL-
ING AF BELASTNING PÅ OPERATIONSLEJET.
• Læs og forstå alle advarsler i denne manual og på selve benholderne før
lejring med en patient.
• Symbolet er beregnet til at advare brugeren om vigtige procedurer
eller sikkerhedsinstruktioner vedrørende brugen af dette produkt.
• Symbolet på etiketterne er beregnet til at vise, hvornår der skal
refereres til IFU’en ved brug.
• De teknikker, der er beskrevet i denne vejledning, er kun producentens
forslag. Det endelige ansvar for patientlejringen i forbindelse med dette
produkt forbliver hos den behandlende læge.
• Benholdernes funktion skal altid kontrolleres før brug.
• Dette positoneringsudstyr må kun betjenes af uddannet personale.
• Alle ændringer, opgraderinger eller reparationer skal udføres af en autoris-
eret specialist.
• Enhver alvorlig hændelse, der er sket i forbindelse med udstyret, skal
indberettes til fabrikanten og den kompetente nationale myndighed, hvor
brugeren bender sig.

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BRUGSANVISNING
1 Brugsanvisning:
1.1 Indikation for anvendelse:
KTEK Curve rygsøjlerammen giver maksimal lordose ved en række forskellige kiru-
rgiske procedurer på rygsøjlen, herunder, men ikke begrænset til, laminektomi, de-
kompression, diskusoperationer og mikrodiskektomioperationer. Disse enheder kan
anvendes til en bred patientpopulation, som det skønnes hensigtsmæssigt af behan-
dleren eller institutionen.
1.2 Anvendelse:
KTEK Curve rygsøjlestøtten er designet til at positionere og støtte patientens rygsø-
jle ved en række kirurgiske indgreb, herunder, men ikke begrænset til, laminektomi,
dekompression, diskusoperation og mikrodiskektomi. Disse enheder er beregnet til at
blive brugt af sundhedspersonale på operationsstuen.
1.3 Tilsigtet bruger- og patienttype:
Tilsigtet brugere: Kirurger, sygeplejersker, læger og/eller sundhedsfagligt personale,
der er involveret i den påtænkte procedure.
Tilsigtede patienttyper: Benholderne er beregnet til at blive brugt til patienter, der ikke
overstiger vægten i det sikre arbejdsbelastningsfelt, der er angivet i produktspecika-
tionen punkt 3.2.
1.4 Risikovurdering:
Dette produkt overholder relevante krav til ydeevne og sikkerhedsstandarder. Skader
på benholderne som følge af misbrug, funktionelle eller mekaniske fejl kan ikke udeluk-
kes. Brugeren er ansvarlig for at sikre, at enheden er forsvarligt fastgjort og fungerer på
en sikker måde.
2 Sikkerhedsovervejelser:
2.1 Meddelelse om sikkerhedsfaresymbol:
MÅ IKKE BRUGES, HVIS PRODUKTET VISER SYNLIGE
SKADER.
2.2 Udstyrs advarsel:
Brug ikke produktet, hvis emballagen er beskadiget eller utilsigtet åbnet før brug. Alle
ændringer, opgraderinger eller reparationer skal udføres af en autoriseret specialist.
2.3 Bortskaffelse:
Brugere bør overholde alle statslige, regionale og / eller lokale love og bestemmelser,
der vedrører sikker bortskaffelse af medicinsk udstyr og tilbehør.
Hvis der opstår tvivl, skal brugeren af benholderne først kontakte Kyra Medical Techni-
cal Support for at få vejledning i sikre bortskaffelsesprocedurer.

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BRUGSANVISNING
Anvendt
symbol Beskrivelse Reference
Angiver, at benholderne er medicinsk udstyr MDR 2017/745
Angiver producenten af medicinsk udstyr EN ISO 15223-1
Angiver producentens serienummer EN ISO 15223-1
Angiver det globale handelsvarenummer for
medicinsk udstyr
21 CFR 830
MDR 2017/745
Angiver producentens LOT-nr EN ISO 15223-1
Angiver den dato, hvor det medicinske udstyr blev
fremstillet EN ISO 15223-1
Angiver producentens katalognummer EN ISO 15223-1
Angiver behovet for, at brugeren konsulterer brug-
sanvisningen for at få vigtige advarselsoplysninger,
f.eks. advarsler og forholdsregler.
EN ISO 15223-1
Angiver at benholderne ikke indeholder naturgummi
eller latex EN ISO 15223-1
Angiver den autoriserede repræsentant i Det Eu-
ropæiske Fællesskab EN ISO 15223-1
Angiver den autoriserede repræsentant i Schweiz EN ISO 15223-1
Angiver den autoriserede repræsentant i Det
Forenede Kongerige EN ISO 15223-1
Angiver, at det medicinske udstyr er i overensstem-
melse med UK MDR 2002 UK MDR 2002
Angiver, at det medicinske udstyr er i overensstem-
melse med FORORDNING (EU) 2017/745 MDR 2017/745
Angiver en advarsel IEC 60601-1
Angiver behovet for, at brugeren konsulterer brug-
sanvisningen EN ISO 15223-1
2.4 Symboler: