Atec Invictus Power T Handle User manual

INS-136 C 12/2023 Page 1 of 7
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 2 of 7
OPERATING CONDITIONS:
•Operating Temperature: 10 degrees C to 40 degrees C
•Relative Humidity: 30% to 75% (Non-condensing)
•Atmospheric Pressure Range: 70kPa - 106kPa
PREOPERATIVE/ INTRAOPERATIVE MANAGEMENT:
1. Always review the instructions for use and caution/warning notices.
2. The surgeon should be thoroughly familiar with the proper operation of the power surgical
instruments and accessories prior to use.
3. Inspect package prior to use for signs of damage or tampering.
4. The circulating nurse opens the package and delivers the contents onto the sterile field.
5. Remove the white tab by firmly pulling the tab out of the device. Discard the pull tab.
6. Pull back on the sliding collar on the Invictus Power T Handle output shaft. Align the
orthopedic instrument with the shaft so that the corners of the ¼ square end of the
attachment line up with the notches on the driver shaft. Insert the orthopedic instrument
into the shaft. Release the sliding collar. Sliding collar should return to the starting
position. If it does not return fully, the instrument is not fully inserted into the shaft.
7. Check for correct engagement of the orthopedic instrument by pulling it slightly.
8. Select forward (“F”) or reverse (“R”) on the black switch. Then press and hold the red
power button. Rotation in the direction selected on the black switch will continue until the
red power button is released or maximum stall torque is produced. 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.
10. Pull the sliding black collar fully back and remove the instrument from the shaft.
POSTOPERATIVE MANAGEMENT:
Postoperative management by the surgeon is essential. This includes instructing, warning, and
monitoring the compliance of the patient.
1. The batteries, which power the product, may be disposed of separately by unscrewing the
six screws (T6) on the undersurface of the driver.
2. The batteries can then be manually removed from the battery clips.
3. Disposal should be done in accordance with applicable regulations, which vary from
country to country.
4. Batteries should not be incinerated.
5. Batteries for disposal should be collected, transported, and disposed of in a manner that
will prevent short-circuit (terminals taped).
6. Recycling of the batteries should be done in authorized facilities.
STORAGE CONDITIONS:
•Ambient temperature out of direct sunlight (10 degrees C to 40 degrees C).
•Expiration date of product is printed on the shelf box label and tray label for each unit.
INSPECTION:
•Inspect each instrument, container, and tray to ensure that all visible contamination has
been removed. If contamination is noted, repeat the cleaning/disinfection process.
•Check the action of moving parts (e.g., hinges, box-locks, connectors, sliding parts, etc.)
to ensure smooth operation throughout the intended range of motion.
•Check instruments with long slender features (particularly rotating instruments) for
distortion.

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•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.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
Compliance level Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7
GHz
3 V/m
80 MHz to 2.7 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the PTH,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
d = [3.5/3] √P 80 MHz to 800 MHz
d = [7/3] √P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the
transmitter in wats (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site survey, should be less than the compliance level
in each frequency range. Interference may occur in
the vicinity of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the PTH is used
exceeds the applicable RF compliance level above, the PTH should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the PTH.

INS-136 C 12/2023 Page 4 of 7
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
IMMUNITY to
proximity fields
from RF wireless
communications
equipment
MHz
– Modulation –
Field
Strength
385 - 18 Hz - 27 V/m
MHz – Modulation –
Field
Strength
385 - 18 Hz - 27 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the PTH, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
450 - 18 Hz - 28 V/m
450 - 18 Hz - 28 V/m
710 - 217 Hz - 9 V/m
710 - 217 Hz - 9 V/m
Recommended separation distance:
745 - 217 Hz - 9 V/m
745 - 217 Hz - 9 V/m
780 - 217 Hz - 9 V/m
780 - 217 Hz - 9 V/m
E = [6/d] √P
810 - 18 Hz - 28 V/m
810 - 18 Hz - 28 V/m
d = [6/E] √P
870 - 18 Hz - 28 V/m
870 - 18 Hz - 28 V/m
930 - 18 Hz - 28 V/m 930 - 18 Hz - 28 V/m
where P is the maximum output power
rating of the transmitter
1720 - 217 Hz - 28 V/m 1720 - 217 Hz - 28 V/m
in wats (W) according to the transmitter
manufacturer, d is the
1845 - 217 Hz - 28 V/m 1845 - 217 Hz - 28 V/m
recommended separation distance in
meters (m), and E is the
1970 - 217 Hz - 28 V/m 1970 - 217 Hz - 28 V/m
field strength in V/m. Field strengths from
fixed RF transmitters,
2450 - 217 Hz - 28 V/m 2450 - 217 Hz - 28 V/m
as determined by an electromagnetic site
survey, should be less
5240 - 217 Hz - 9 V/m 5240 - 217 Hz - 9 V/m
than the compliance level in each
frequency range. Interference
5500 - 217 Hz - 9 V/m 5500 - 217 Hz - 9 V/m
may occur in the vicinity of equipment
marked with the following
5785 - 217 Hz - 9 V/m
5785 - 217 Hz - 9 V/m
symbol:
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Recommended separation distances between portable and mobile RF communications equipment as well as mobile RF
communications equipment and PTH
The PTH is intended for use in an Electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the PTH can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the PTH as recommended below,
according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output power
of transmitter (W)
80 to 800 MHz 800 MHz to 2.7 GHz 710, 745, 780,
5240, 5500, 5785
385, 450,810, 870, 930,
1720, 1845, 1970, 2450
d = [3.5/3] √P
d = [7/3] √P
d = [6/9] √P
d = [6/28] √P
0.01
0.117
0.233
0.067
0.021
0.1
0.369
0.738
0.211
0.070
1
1.167
2.333
0.667
0.214
10
3.689
7.379
2.108
0.700
100
11.667
23.333
6.670
2.143
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in wats (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
from structures, objects, and people.

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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. Otherwise, degradation of the
performance of this equipment could result.
WARNING: A risk of increased emissions or decreased immunity may result if any additional
cables are attached.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
1 Guidance and manufacturer’s declaration – electromagnetic emissions
2 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.
3 Emissions test Compliance Electromagnetic environment - guidance
4 RF emissions
CISPR 11 Group 1
The PTH uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
6 RF emissions
CISPR 11 Class A
The PTH is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
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
Electrostatic discharge
(ESD)
IEC 61000-4-2
+8kV contact
+ 15kV air
+8kV contact
+ 15kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.

INS-136 C 12/2023 Page 6 of 7
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
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz to 2.7 GHz
3 V/m
80 MHz to 2.7 GHz
Portable and mobile RF communications equipment should
be used no closer to any part of the PTH, including cables,
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = [3.5/3] √P 80 MHz to 800 MHz
d = [7/3] √P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter
in wats (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m). Field
strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the
compliance level in each frequency range. Interference may
occur in the vicinity of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the PTH is used exceeds the applicable RF
compliance level above, the PTH should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the PTH.
RETURNING INSTRUMENTS TO ALPHATEC SPINE:
All used products returning to Alphatec Spine must undergo all steps of cleaning, inspection, and
terminal sterilization before being returned to Alphatec Spine. Documentation of decontamination
should be included.
UDI CONSTRUCTION
To compile a unique device identifier (UDI) for reusable, reprocessed devices, the device identifier
(GTIN) may be ascertained by searching for the part number in the FDA GUDID at
https://accessgudid.nlm.nih.gov/. The production identifier(s) (e.g., lot number, serial number)
may be found directly marked on the device.
COMPLAINT HANDLING / REPORTING:
All product complaints relating to safety, efficacy or performance of the product should be reported
immediately to Alphatec Spine by telephone, e-mail, or letter, per contact information below. All
complaints should be accompanied by name, part number, and lot numbers. The person
formulating the complaint should provide their name, address, and as many details as possible.
You may contact Customer Service directly at [email protected].

INS-136 C 12/2023 Page 7 of 7
For Surgical Technique Guides or additional information regarding the products, please contact
your local representative or Alphatec Spine, Inc., Customer Service directly at
[email protected].
CAUTION: Federal law (USA) restricts these devices to sale by or on the order
of a physician.
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. All other trademarks belong to their respective owners. For patent information, please visit
https://atecspine.com/patent-marking/. © 2023 Alphatec Spine, Inc. All rights reserved.