Medtronic SPS03112 Instructions for Use

www.medtorque.com

IFU-002 Rev. D

INSTRUCTIONS FOR USE (IFU)

Torque-Limiting Drivers

DESCRIPTION/INDICATIONS

MedTorque, Inc. instruments consist of Class I manual
surgical instruments. The torque-limiting drivers designed
and manufactured by MedTorque, Inc. are reusable
surgical instruments that are intended to limit the applied
moment of force, or torque, in the clockwise (CW) direction
to a device or fastener during the tightening process.
The torque-limiting drivers utilize an internal mechanism
that is factory set to actuate at a predetermined value
within an accuracy ±10% throughout its duty life which
includes use, cleaning, sterilizing, and storage. When
actuated, the mechanism produces an audible and tactile
click that is noticeable to the user.

IMPORTANT PRECAUTIONS AND SAFETY INSTRUCTIONS

• Read this document prior to using the torque-limiting

instrument.

• Only use torque-limiting products as intended.

• The calibration period of six (6) months is established

by MedTorque, Inc. and should be closely followed to
ensure acceptable performance of product.

• MedTorque, Inc. is the only authorized provider of

service and calibration for torque-limiting products.
Service provided by non-authorized party will void
warranty.

• Inspect prior to use. Do not use or discontinue use if

device is damaged, malfunctioning or performance is
in question.

• If product has been dropped, impacted or used

improperly, a recalibration should be performed.

• To avoid damaging device:

o Never use torque-limiting drivers in the counter-

clockwise (CCW) direction to break loose a
fastener.

o Never impact on torque-limiting drivers or use as an

impacting device on other devices.

o Never use as a prying tool.
o Never expose torque-limiting drivers to extreme

temperatures.

USAGE INSTRUCTIONS

New users of torque-limiting drivers should become
familiar with their function prior to using in a clinical
setting.

• Engage the torque-limiting driver with the mating shaft

and ensure it is secured in the coupling.

• Grip the handle of the torque-limiting driver in such a

way that is comfortable in actuating the torque-limiting
driver throughout the tightening process.

• Align the axis of the torque-limiter with the axis of the

driven fastener. The angle θ° is the deviation

symmetrically about the axis of the fastener. This
angle, θ°, should not exceed 5° as shown in Figures 1
through 3.

• Apply a rotational force (τ) to the handle in the

clockwise (CW) direction along the aligned axes. This
force should be applied continuously and consistently
until the torque-limiter actuates. The actuation is
characterized by an audible and tactile click. The
torque-limiter should be actuated in the span of
approximately 1 second.

• Do Not:
o Operate the torque-limiter in a counter-clockwise

(CCW) direction.

o Apply additional compound loads such as bending

or compressing to the torque-limiting driver while
actuating.

o Apply a side load to coupling while actuating as it

may increase actuation value.

o Apply rotational force either too rapidly (<0.5 secs

per actuation) or too slowly (>2 secs per actuation).

o Continue to use torque-limiter if there is doubt that

it is operating correctly.

Figure 2 - Axial Torque-Limiter with T-Handle

Figure 1 - Axial Torque-Limiter

Figure 3 – Mondo T-Handle Torque-Limiter

IFU-002 Rev D Status: RELEASED printed 1/3/2020 8:13:07 AM by Eric Walker

www.medtorque.com

IFU-002 Rev. D

WARNING

1. Instruments are provided non-sterile and must be

cleaned and sterilized prior to use.

2. Surgical instruments should only be used and

reprocessed by qualified healthcare practitioners.

3. Torque-Limiting Drivers and Handles are not designed

for disassembly before cleaning.

4. Cleaning of small holes and cannulation requires

special attention.

5. To avoid damage (pitting, rusting), avoid highly

aggressive agents (NaOH, NaOCL), and salt solutions.

6. Clean and sterilize before first use and before

returning them to service in accordance with ISO
17665-1:2006 Sterilization of Health Care Products –
Moist Heat – Part 1.

INFORMATION

1. Instruments that are damaged should be reprocessed

prior to return to the manufacturer for repair.

2. These cleaning methods have been validated by a

third-party lab. Other means of cleaning may be
suitable; however, it is advisable that the cleaning
method(s) be validated in accordance with the
equipment manufacturer's recommendations.

POINT OF USE

1. Wipe instruments to remove visible soil.

2. Keep instruments moist, preferably submerged in

cold water (<40°C) immediately after use.

MANUAL CLEANING

1. Submerge instruments in a pH neutral enzymatic

cleaning agent or detergent (pH <8.5) solution for 10
to 15 minutes. Do not use aldehyde fixating
detergents because they can cross-link the protein
residues, making it difficult to remove soiling. Follow
detergent manufacturer's instructions for mixing
ratios and temperature.

2. Use a soft bristle brush if needed to remove visible

soil from surfaces. Give special attention to uneven
surfaces (such as knurled handles) and drilled
holes/cannulation. Use flexible bottle brush, syringes,
or aspiration for hard to reach places such as
cannulation.

RINSE IN RUNNING WATER

1. Thoroughly rinse with de-ionized or sterile, purified

water, (<40°C), until it is no longer slippery to the
touch, for a minimum of 2 minutes. Use a syringe to
apply rinsing solution under pressure to hard to reach
areas such as cannulations and drilled holes.

2. Visually inspect instruments for remaining debris,

paying special attention to hard to reach areas.
Repeat rinsing steps if needed until no visible soiling
remains.

3. Drain instruments on single-use drying paper or lint-

free towel.

ULTRASONIC CLEANING

1. Submerge instrument in ultrasonic bath with pH

neutral enzymatic cleaning agent or detergent, (pH
<8.5), solution. Follow detergent manufacturer's
instructions for mixing ratios and temperature.

2. Soak at 25 to 45 kHz for 10 to 15 minutes. Visually

ensure complete immersion of instruments.

RINSE IN RUNNING WATER

1. Thoroughly rinse with de-ionized or sterile, purified

water, (<40°C), until it is no longer slippery to the
touch, for a minimum of 2 minutes. Use a syringe to
apply rinsing solution under pressure to hard to reach
areas such as cannulations and drilled holes.

2. Visually inspect instruments for remaining debris,

paying special attention to hard to reach areas.
Repeat rinsing steps if needed until no visible soiling
remains.

3. Drain instruments on single-use blotting paper.

DRY INSTRUMENTS

1. Thoroughly dry instruments with a soft, lint-free

clothe, with single-use drying paper, or with medical
grade, filtered, compressed air. Hard to reach areas
such as drilled holes and cannulations should be
dried with medical compressed air.

INSPECT INSTRUMENTS

1. Visually inspect instruments before sterilization. This

is typically done under normal lighting and without
magnification.

2. Visually inspect for soiling, corrosion, cracks, and

damage to components.

3. Functionally inspect adapters (if equipped) to ensure

they connect onto mating shafts. Check function of
ratcheting screwdrivers in both directions, (forward
and reverse).

4. Notify appropriate personnel regarding damage and

malfunctioning components.

STERILIZATION

1. Sterilization testing has been performed in

accordance with ISO 17665-1:2006 Sterilization of
Health Care Products – Moist Heat – Part 1

a. Gravity: 250°F, 30 min exposure, 45 min dry

time

2. After dry time allow a minimum of ten minutes for

equilibration period to allow instrument to cool to
room temperature.

3. See Implant / Instrument System manufacturer's

Instructions.

MAINTENANCE

1. Lubricate moving parts and threads with a water-

based surgical grade instrument lubricant. Follow
lubricant manufacturer's instructions.

STORAGE/HANDLING

1. Handle instruments with care. Scratches and surface

damage can minimize the usable life of the
instrument and increase the risk of corrosion.

2. Store sterilized instruments in a clean, dry, dust-free

environment at temperatures between 5°C and
40°C. Avoid areas of humidity to reduce the risk of
corrosion.

MedTorque, Inc.
5601 95th Ave
Kenosha, WI 53144
P [phone]
F [phone]

IFU-002 Rev D Status: RELEASED printed 1/3/2020 8:13:07 AM by Eric Walker