KYRA MEDICAL k-tek KTEK2340 User manual

Kyra Medical, Inc.
102 Otis St.
Northborough, MA 01532
United States of America
Secondary
Shoulder Supports:
KTEK2340
IFU 03-0371 REV G©2023 Kyra Medical, Inc. 1
Secondary
Shoulder Supports
Instructions for Use
ENGLISH

IFU 03-0371 REV G©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 safe-
ty 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
DISTRIBUTON OF THE OPERATING ROOM TABLE
INSTRUCTIONS FOR USE

IFU 03-0371 REV G©2023 Kyra Medical, Inc. 3
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 3.1.
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 03-0371 REV G©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 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
INSTRUCTIONS FOR USE

IFU 03-0371 REV G©2023 Kyra Medical, Inc. 5
3 System:
3.1ProductSpecication
MechanicalSpecications Description
Product Dimensions 9" x 7" x 14" (L x W x H) approx.
23 cm x 18 cm x 35 cm
Material Stainless Steel, Aluminum, Urethane coated
viscoelastic foam.
Safe Working Load on the
Device Do not exceed 600 lbs. (272 kg) patient weight.
Overall Weight of Device 5 lbs. (2.3 kg)
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: Round Post Clamp x 2
Operating Room Table Compat-
ibility
Compatible with the following surgical table rail
styles: US, UK, EU, DEN, JP, based on clamp
selection.
3.2 System Setup and Use:
INSTRUCTIONS FOR USE