Atec Invictus Power T Handle Instructions For Use Manual

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Invictus
Power T Handle
®
INSTRUCTIONS FOR USE

INDICATIONS FOR USE

The Invictus Power T Handle is a single-use battery powered driver intended for use during
surgical procedures to power various orthopedic accessories or attachments. The Invictus Power
T Handle is also intended for use as a non-powered hand-held device for manual use with
orthopedic instruments.

PRINCIPLE OF OPERATION

The Invictus Power T Handle motor is powered by 2 lithium metal-oxide batteries, 4.0 volts each.
The batteries are located in the grip portion of the driver. The motor and reducing gears are
located in the body of the driver. The output shaft connects to orthopedic accessories through a
standard ¼ inch square connection. There is an automatic output shaft locking component that
allows the driver to also function as a manual T handle.

WARNINGS/CAUTIONS/PRECAUTIONS:

1. This device has been designed for single use only. Reuse, reprocessing, resterilization,
or repackaging may compromise the structural integrity and/or essential material and
design characteristics that are critical to the overall performance of the device and may
lead to device failure which may result in injury to the patient.
2. Reuse, reprocessing, resterilization, or repackaging may also create a risk of
contamination of the device and/or cause patient infection or cross infection, including,
but not limited to, the transmission of infectious disease from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient or end user.
3. Device is not intended to be modified, serviced, or repaired.
4. Do not use in an oxygen-enriched atmosphere.
5. Do not incinerate the batteries as this can cause a risk to the environment.
6. Do not recharge batteries, put in backwards, or mix with used or other battery types as
these actions may cause explosion or leakage leading to personal injury or can cause a
risk to the environment.
7. After use, this product may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and applicable local, state, and federal laws
and regulations.
8. Follow Occupation Safety and Health Administration (OSHA) standards or Universal
Precautions for blood borne pathogens.
9. In order to limit contact with infectious agents from splashing, personnel using or patient
exposed to the Invictus Power T Handle must wear personal protective equipment.
10. If device becomes objectionably warm during normal operation, discontinue use of device.
11. Soft tissue contact with rotating output shaft should be avoided to prevent soft tissue
damage.
12. Federal law restricts this device for sale by or on the order of a medical practitioner licensed
to do so.
13. If package is damaged or open, do not use product.
14. Read all instructions prior to use.
15. Do not submerge handle in liquid as this may compromise the battery and motor for the
driver.
16. Power T Handle operates at a continuous amperage which does not allow for speed control
and is not torque-limiting. Do not use Power T Handle with torque-sensitive devices.
INS-136 C
12/2023
Page 1 of 7

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Summary of Contents for Atec Invictus Power T Handle

  • Page 1 PRINCIPLE OF OPERATION The Invictus Power T Handle motor is powered by 2 lithium metal-oxide batteries, 4.0 volts each. The batteries are located in the grip portion of the driver. The motor and reducing gears are located in the body of the driver. The output shaft connects to orthopedic accessories through a standard ¼...
  • Page 2 This is a noncontinuous device with maximum operating time of 15s and a minimum duty off time of 30s. 9. Grasp the handle of the Invictus Power T Handle and turn the entire driver in the forward or reverse direction.
  • Page 3 Drill bits, reamers, rasps, and other cutting instruments should be inspected after • processing with alkaline detergents. Inspect instruments for any other damage, wear, and/or corrosion. • ELECTROMAGNETIC COMPATIBILITY: Guidance and manufacturer’s declaration – electromagnetic immunity The PTH is intended for use in the electromagnetic environment specified below. The customer or the user of the PTH should assure that it is used in such an environment.
  • Page 4 Guidance and manufacturer’s declaration – electromagnetic immunity The PTH is intended for use in the electromagnetic environment specified below. The customer or the user of the PTH should assure that it is used in such an environment. IMMUNITY TEST IEC 60601 TEST LEVEL Compliance level Electromagnetic environment - guidance Portable and mobile RF communications...
  • Page 5 The Invictus Power T Handle (PTH) requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the below tables. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PTH, including cables specified by the manufacturer.
  • Page 6 Guidance and manufacturer’s declaration – electromagnetic immunity The PTH is intended for use in the electromagnetic environment specified below. The customer or the user of the PTH should assure that it is used in such an environment. IMMUNITY IEC 60601 TEST Compliance level Electromagnetic environment - guidance TEST...
  • Page 7 For a listing of Symbols and Explanations, see atecspine.com/eifu Alphatec Spine, ATEC Spine, the ATEC logo, EOS, Invictus, and Power T Handle are trademarks or registered trademarks of Alphatec Holdings, Inc., its affiliates and/or subsidiary companies, registered in the USA and other countries.

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