Page 1
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Form 7.2.2-22 02/04/2020 Rev. 0 Page 1 of 4
Spinal & Orthopedic Instrument Specialists
10325 58th Place
Kenosha, WI 53144
262.925.1374
1.877.201.7661
Fax: 262.925.1380
Introduction
Bradshaw Medical designs and manufactures Torque Limiting Ratcheting Drivers for use in spinal and orthopedic surgeries.
All hand torque tools must be handled with care. The Torque Limiting Ratcheting Driver is indicated for any scenario where a
clinician desires to increase efficiency when tightening or loosening fasteners in a surgical setting. This increase in efficiency is
achieved by providing the option of allowing torque to be applied to a fastener in only one rotational direction and limiting the
magnitude of torque that can be applied. The Torque Limiting Ratcheting Driver is intended for use by trained surgeons,
medical professionals, and others trained with appropriate use. The use of this instrument should not be performed without
prior instruction by an experienced individual. When used within the guidelines of this document, this device will maintain a
high level of performance for the lifetime (3 years) of the device. Failure to abide by these guidelines could compromise device
performance, durability, and possibly cause serious injury.
Intended Use
All Torque Limiting Ratcheting Driver must be handled with care and must be used by experienced medical professionals or
other qualified individuals. BMI is not aware of any contraindications with regards to the Torque Limiting Ratcheting Driver
but continues to monitor the use and application of these devices. Use as intended only.
The Torque Limiting Ratcheting Driver is able to operate in 3 specific settings: forward, reverse, and neutral.
When in the forward setting, torque applied by the clinician in the reverse direction allows the Torque Limiting Ratcheting
Driver to quickly and easily rotate the driver to reposition the hand for the next driving stroke with minimal torque application
to the fastener. This allows for no change in hand position as the fastener is inserted.
When in the reverse setting, torque applied by the clinician in the forward direction allows the Torque Limiting Ratcheting
Driver to quickly and easily rotate the driver to reposition the hand for the next driving stroke with minimal application to the
fastener. This allows for no change in hand position as the fastener is removed.
When in the neutral setting, torque applied in either direction by the clinician is transferred to a fastener.
The Torque Limiting Ratcheting Driver utilizes a selector ring that allows the clinician to shift between the 3 distinct
settings. The clinician is required to pull the selector ring away from the instruments body slightly and apply a minimal amount
of torque to the selector ring in order to shift between settings, with specific marking indicating which setting the clinician is
employing.
The Torque Limiting Ratcheting Driver is a reusable surgical instrument designed to limit the magnitude of torque applied to
another device or fastener. The device produces an audible and tactile ‘click’ when the calibrated torque limit is reached. It is
offered from the factory at torque settings between 50-135 in-lbs. (5.65-15.25 N-m) and will maintain a torque accuracy of
±10% of the set value through repeated usage and cleaning/sterilization cycles.
Important Precautions and Safety Instructions
1. Read the Instruction for Use completely before operating the Torque Limiting Ratcheting Driver. Failure to read the
manual could result in harmful effects to the user, patient, and/or the device.
2. Maintain this device in accordance with the BMI “Guidelines for Instrument Care”.
3. Inspect before every use. Do not use if device is damaged. Only use if the device is in good functional condition.
4. Bradshaw Medical recommends manual torque verification at every inbound and outbound device transaction to ensure
device integrity before use.
5. Discontinue use immediately if there is abnormal noise or vibration or if device appears to be malfunctioning/damaged.
6. This device is a hand tool and is not intended to be used in conjunction with other devices for increased advantage or
leverage.
7. Do not drop or throw the device. If the device is dropped, manually verify the device’s torque limit with calibrated torque
measuring equipment.
8. To avoid damaging the device:
a. Do not use this torque wrench to break fasteners loose.
b. Do not use in the counter-clockwise direction unless the unit is specifically designed for this usage.
c. Do not impact this device or use this device to impact other devices.
d. Do not use as a prying tool.
Page 2
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Form 7.2.2-22 02/04/2020 Rev. 0 Page 2 of 4
Spinal & Orthopedic Instrument Specialists
10325 58th Place
Kenosha, WI 53144
262.925.1374
1.877.201.7661
Fax: 262.925.1380
e. Do not use other tools or instruments to aid in rotating the handle. If the device cannot be actuated by hand,
discontinue use immediately.
f. Do not expose to temperature less than -10°F (-23.3°C) or greater than 325°F (162.8°C).
g. Do not use for any technique other than tightening fasteners.
Usage Instruction
For first time users of BMI’s Torque Limiting Ratcheting Driver, operate the device and become familiar with the function
PRIOR to using it in a surgical environment. The Torque Limiting Ratcheting Driver is shipped non-sterile and must be
sterilized per the recommended instructions before use in a surgical setting.
1. For units with an adaptor, insert the shaft into the adaptor of the Torque Limiting Ratcheting Driver (typically the
depression of the adaptor collar is required to allow shaft insertion). Verify that the adaptor is locked, and the driving shaft
is fully secured in the adaptor.
2. Grip the handle as shown in Figure 1 with either one hand or both hands.
Figure 1: The operator can use the device with either one hand (left picture) or both hands (right picture).
3. Orient the Torque Limiting Ratcheting Driver such that its axis of rotation is colinear to the axis of the external device
being driven (Refer to Figure 2).
a. Proper orientation is critical: the axis of rotation must be aligned with the axis of the external device within
approximately 5° in all directions.
Figure 2: Proper orientation of device during use.
4. Apply torque to the handle smoothly and continuously until the device completes one actuation. Completion of 1 actuation
can be identified by a single tactile vibration and accompanied by an audible ‘click’.
a. Speed: From start to finish a single actuation should occur within 0.5-1.5 seconds.
b. Application of Load: Apply pure torsion in the appropriate driving direction only.
i. Do not apply any additional loads to the device during an actuation (tension, compression, bending).
ii. Do not rotate the handle extremely fast (<0.5 sec/actuation) or extremely slow (>3 sec/actuation).
iii. Do not continue to rotate the handle if there is any knowledge or suspicion that the device or components within
the device are not functioning properly.
*Note* Failure to follow these guidelines may result in the device malfunctioning.
5. If multiple actuations are required, reset your grip after every actuation and repeat steps 2-4.
6. To adjust the direction of the Ratcheting mechanism portion of the device: Determine the setting desired for the Ratcheting
Driver. To change the Ratcheting Driver to the desired setting pull the selector ring away from the device body and apply
Page 3
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Form 7.2.2-22 02/04/2020 Rev. 0 Page 3 of 4
Spinal & Orthopedic Instrument Specialists
10325 58th Place
Kenosha, WI 53144
262.925.1374
1.877.201.7661
Fax: 262.925.1380
torque to the selector ring in the direction towards the illustrated setting on the face of the device. A quiet click sound can
be heard to inform the user the Selector Ring is in the proper position. See Figure 3 for reference.
Figure 3: Changing Ratchet directions
Return and Service Instructions
If this device requires return or service, please contact the BMI Service Department at 1-877-201-7661. A BMI issued RMA
is required to return the instrument to BMI.
Manufactured By: Bradshaw Medical
10325 58th Place
Kenosha, WI 53144
USA
(262) 925-1374
Fax: (262) 925-1380
www. bradshaw-medical.com
Symbols Glossary
Reference Number of Symbol
Title of Symbol
Description of Symbol
5.1.1
Manufacturer
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
5.12
Authorized representative in the European
Community
Indicates the authorized representative in the
European Community.
5.1.3
Date of manufacture
Indicates the date when the medical device was
manufactured.
5.1.4
Use-by-date
Indicates the date after which the medical device
is not to be used.
5.1.5
Batch code
Indicates the manufacture’s batch code so that
the batch or lot can be identified.
5.1.6
Catalogue number
Indicates the manufacturer’s catalogue number so
that the medical device can be identified.
5.2.7
Non-sterile
Indicates a medical device that has not been
subjected to a sterilization process.
5.4.3
Consult instructions for use
Indicates the need for the user to consult the
instructions for use.
Each Symbol in the ISO/IEC symbols database ISO 15223-1:2012(F)
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Torque Limiting Ratcheting Driver: Instruction for Use (IFU)
Torque Limiting Ratcheting Driver Driver: Instruction for Use (IFU)
Form XXXX Page 4 of 4
Spinal & Orthopedic Instrument Specialists
10325 58th Place
Kenosha, WI 53144
262.925.1374
1.877.201.7661
Fax: 262.925.1380
Additional Cleaning and Repeated Processing Information
WARNINGS:
• Avoid contact with: Strong Acids such as Hydrochloric Acid and Sulfuric Acid, Hydrogen Fluoride,
Alkaline and high concentrations of chlorides such as Chlorine Bleach.
• No specific enzymatic detergent is endorsed, but the final solution should have a pH between 7.0 and 8.5
according to ASTM F1744-96 (2008).
• NEWLY PURCHASED DEVICES MUST UNDERGO DECONTAMINATION PRIOR TO
STERILIZATION.
• When using any detergent or equipment, always follow the manufactures’ instructions/recommendations
for that product.
Limitations on Reprocessing: Repeated reprocessing has minimal effects on the performance of this device.
Instructions
Preparations for
Decontamination:
• Immediately after use, this device should be presoaked in an enzymatic detergent bath safe for medical
devices for 5 minutes. The time and temperature of this soak should follow manufacturer’s instruction.
• Scrub the submerged device(s) with a soft bristle brush. Agitate the device while scrubbing. Actuate
moving parts. Use a small cytology brush to clean internal channels.
• Clean the cannulated devices using a small brush through the cannulation
• Ultrasonically clean the instrument(s) for 10 minutes in a neutral pH detergent (or acceptable alternative).
Prepare the detergent according to the manufacturer’s recommendation.
• After presoak, the device must be rinsed in demineralized water.
Cleaning
(Automated):
• An automatic cleaning device such as an ultrasonic cleaner is always preferred over manual cleaning
when available.
• Ultrasonically clean the device(s) for 10 minutes in a neutral pH detergent (or acceptable alternative).
Prepare the detergent according to the manufacturer’s recommendations.
• Run the automatic wash cycle with a temperature of 40°C and ultrasonic waves of 35 kHz for 10 minutes.
These times and temperatures will vary depending on the equipment and detergent used.
• Following cleaning, thoroughly rinse the device with demineralized water for at least 1 minutes to
remove any debris or detergents.
• Repeat this cleaning procedure if the device(s) appear to be soiled after initial cleaning.
• Only use an automatic cleaner that has been properly maintained and cleaned.
Cleaning
(Manual):
• Submerge the device(s) in an enzymatic detergent that is safe for medical devices. Prepare the detergent
according to manufacturer’s recommendations. Soak the device(s) for 5 minutes in the detergent.
• Scrub the submerged device(s) with a soft bristled brush to remove any remaining soil or debris, paying
special attention to small groves, crevices and cannulation. Agitate the device(s) in the solution while
scrubbing. Use a small cytology brush to clean internal channels. Actuate any movable parts to loosen any
trapped soil.
• Rinse thoroughly with warm (38-49°C) demineralized water. Agitate the device for at least 3 minutes.
• Check this device for any visible soil and repeat the cleaning process if soil is found. (A longer presoak
may be necessary).
• Rinse the device(s) with clean tap water for at least 1 minute. If the water leaving the device appears to be
soiled, repeat the cleaning procedure.
• Dry the exterior of the device(s) with a clean, lint-free cloth.
• DO NOT use any abrasive detergents, or cleaning pads. All brushes used should be designed for use on
medical devices.
Recommended
Sterilization
Pre-Vacuum
Gravity
Cycle:
Double wrapped
Cycle:
Double Wrapped
Temperature:
135°C (275°F)
Temperature:
135°C (275°F)
Exposure Time:
3 minutes
Exposure Time:
10 minutes
Dry Time:
20 minutes
Dry Time:
20 minutes
*NOTE* After a steam sterilization cycle the device must be allowed to cool for a minimum of 40 minutes in
(stagnant) open air or 30 minutes under forced air prior to being used. Failure to allow for proper cooling can
adversely affect torque performance.
Inspection:
• Ensure that there are no spots or stains on the device after cleaning/disinfection.
• If such spots exist, repeat the cleaning process to remove any protein residues or other stains.
Packaging:
• Ensure the device has dried and is free of spots prior to packaging.
• Ensure that the packaging material has been held at room temperature for a minimum of 2 hours before
use.
• Package the device using standard packaging materials and packaging practices accepted by the
institution.
Storage:
• No particular requirements; however, should be stored in an area that protects them from dusts, moisture,
insects, vermin and extremes of temperature and humidity. Follow institution’s storage policies.
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