KYRA MEDICAL k-tek KTEK4600 Series User manual

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
KTEK™Secure-Release Clamps:
KTEK4100, KTEK4200
KTEK4300, KTEK4400, KTEK4500
KTEK™Select Clamps:
KTEK4600 Series
KTEK™Simple Clamps:
KTEK4700 Series
KTEK™Round Post Clamps:
KTEK4800 Series
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KTEK™Clamps
Instructions for Use
ENGLISH

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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
referenced 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
specialist.
• Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the national competent authority where the
user is located.
NEVER EXCEED THE WEIGHT CAPACITY AND LOAD DIS-
TRIBUTON OF THE OPERATING ROOM TABLE
INSTRUCTIONS FOR USE

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1 Instructions for Use:
1.1 Indication for Use:
These products are used in a variety of surgical procedures including, but not limited to
gynecology, urology, laparoscopy, colorectal, general, and robotic surgery. These devic-
es are capable of being used with a broad patient population as deemed appropriate by
the caregiver or institution.
1.2 Intended Use:
These products are designed to position and support the patient in a variety of surgical
procedures including, but not limited to gynecology, urology, laparoscopy, general and
robotic 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

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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 Euro-
pean Community 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
Indicates the clamp area that should be facing up-
wards EN ISO 15223-1
INSTRUCTIONS FOR USE

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3 System:
3.1SystemComponetsIdentication:
1. Removal Button
2. Knob
3. Clamp body – Rail specic
3
2
1
MechanicalSpecications Description
Product Dimensions 3" x 2" x 2" (L x W x H) approx.
76 mm x 54 mm x 54 mm
Material Stainless Steel, Aluminum, and Low temperature
Polymers.
Safe Working Load on the
Device Do not exceed 800 lbs. (363 kg) patient weight.)
Overall Weight of Device
• KTEK Select-Release: .86 lbs. (.39 kg)
• KTEK Select Blade: .67 lbs. (.31 kg)
• KTEK Simple Blade: .43 lbs. (.20 kg)
• KTEK Round Post: .67 lbs. (.31kg)
StorageSpecications Description
Storage Temperature -20ᵒ F to 140ᵒ F (-29ᵒ C to +60ᵒ C)
Storage Relative Humidity
Range 15% to 85%
Operating Temperature This device is intended to be used in a controlled
Operating Room environment.
Operating Relative Humidity
Range
CompatibilitySpecications Description
Compatible with:
KTEK Stirrups and accessories
• KTEK Blade clamps: 1" x .25" in. (2.5 x .6 cm)
• KTEK Round Post: .6875" in. (1.8 cm)
Operating Room Table Compat-
ibility
Compatible with the following surgical table rail
styles: US, UK, EU, DEN, JP, based on clamp
selection.
3.2ProductSpecication
INSTRUCTIONS FOR USE

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3.3 System Setup and Use:
3.4 Removal:
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.)
1
2
INSTRUCTIONS FOR USE

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• 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
INSTRUCTIONS FOR USE

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
KTEK™Secure-Release Clamps:
KTEK4100, KTEK4200
KTEK4300, KTEK4400, KTEK4500
KTEK™Select Clamps:
KTEK4600 Series
KTEK™Simple Clamps:
KTEK4700 Series
KTEK™Round Post Clamps:
KTEK4800 Series
IFU 03-0190 REV L©2023 Kyra Medical, Inc. 8
KTEK™Clamps
使用须知

IFU 03-0190 REV L©2023 Kyra Medical, Inc. 9
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。

IFU 03-0190 REV L©2023 Kyra Medical, Inc. 10
用说明
1 使用说明:
1.1 适用范围:
这些产品用于各种外科手术，包括但不限于妇科、泌尿科、腹腔镜、结直肠、普通和机器人手
术。这些设备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:
这些产品设计用于在各种外科手术中定位和支持病人，包括但不限于妇科、泌尿科、腹腔
镜、普通和机器人手术。这些设备旨在由手术室内的医护人员使用。
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。