OctoBase™ 28701
Retractor Rack
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by
or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party
trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered
trademarks of a Medtronic entity in the United States and/or in other countries.
OctoBase™
Explanation of symbols on package labeling
Refer to the outer package label to see which symbols apply to this product.
Lot number
For US audiences only
Quantity
Nonsterile
Consult instructions for use at this website
Manufacturer
Date of manufacture
Do not use if package is damaged
Catalog number
3
Figure 1. Product features and accessories
1 28701 Retractor rack
EN
2 28702 Blank insert set
3 28703 Swivel blade set,
standard
4 28704 Swivel blade set, deep
5 28705 Fixed blade set, standard
6 28706 Fixed blade set, deep
7 28707 Suture holding insert set
8 28709 Handle
9 28710 Fixed skirted blade set
4
1 Product description
OctoBase retractor rack Model 28701
2 Indications for use
The OctoBase retractor rack is intended to provide surgical access by
retraction of soft and bony tissue.
3 Precautions
Proper surgical procedures and techniques are the responsibility of the
medical professional. Surgeons must evaluate the appropriateness of any
procedure based on their own medical training and experience.
4 Adverse effects
None known.
5 Processing and reprocessing
Medtronic has validated the following instructions for preparing this medical
device for reuse. It remains the responsibility of the processor to ensure that
the processing, as actually performed using equipment, materials, and
personnel in the processing facility, achieves the desired result. Processing
requires validation and routine monitoring. Likewise, any deviation by the
processor from the following instructions should be properly evaluated for
effectiveness and potential adverse consequences. Cleaning may be done
manually, or it may be automated according to these Instructions for Use or an
equivalent, validated method.
5.1 Cleaning
Warning: Thoroughly clean the device to eliminate soil prior to sterilization.
Warning: Do not use solvent-based cleaners (for example, acetone or
toluene).
• Do not allow contaminated devices to dry before implementing any
cleaning procedure.
• Reprocess devices within 2 hours after use. If transport to the processing
area will be delayed, place the device in a covered container with an
enzymatic detergent to prevent drying.
• If the device contains multiple components, completely disassemble the
components prior to cleaning per these Instructions for Use.
• Examine the device for cracking or degradation prior to use. Do not use
the device if any components show signs of cracking or degradation.
• Thermal disinfection is not required because the devices are terminally
sterilized.
5.1.1 Manual cleaning
Medtronic has established the following manual cleaning procedure in
Table 1. These steps must be performed within a maximum of 2 hours after
use.
Note: If the device has movable parts, ensure that all surface areas have been
thoroughly cleaned.
Table 1. Manual cleaning instructions
Step Process Temperature Cleaning instructions
1 Rinsing >27°C (>81°F) Remove gross soil using running
water for 1 min. Use a soft-bristle
brush (for example, a nylon toothbrush) to clean the device thoroughly.
2 Soaking >28°C (>82°F) Submerge the device completely for
a minimum of 5 min with 15.6 mL/1 L
(or 2 ounces/1 gallon) of an enzymatic detergent (for example,
5
Table 1. Manual cleaning instructions (continued)
Step Process Temperature Cleaning instructions
ENZOL™) and water. Remove visible soil with a soft-bristled brush.
3 Ultra-
sonic
clean
>27°C (>81°F) Submerge the device completely in
an ultrasonic cleaner (for example,
Bransonic™) with 7.8 mL/1 L (or 1
ounce/1 gallon) of an enzymatic
detergent (for example, ENZOL)
and water. Sonicate for 10 min.
4 Rinsing >27°C (>81°F) Rinse the device with running water
for 1 min.
5 Drying N/A Dry with a clean, lint-free wipe.
6 Inspec-
tion
N/A Visually inspect each device for any
remaining soil or moisture. If soil
remains, repeat the process.
5.1.2 Automated cleaning
Medtronic has established the following automated cleaning procedure. The
steps in Table 2 must be performed within a maximum of 2 hours after use.
Note: If the device or component has movable parts, ensure that all surface
areas have been thoroughly cleaned.
Table 2. Pretreatment instructions
Water tempera-
Step Process
ture Cleaning instructions
1 Rinsing >25°C (>77°F) Remove gross soil using running
tap water.
2 Soaking >25°C (>77°F) Submerge the device completely
for a minimum of 1 min with
7.8 mL/1 L (or 1 ounce/1 gallon)
of an enzymatic detergent (for
example, ENZOL) and water.
Remove visible soil with a softbristled brush (for example, a
nylon toothbrush).
3 Rinsing >25°C (>77°F) Rinse the device for a minimum of
2 min.
4 Inspec-
tion
N/A Visually inspect the device for
any remaining soil. If needed,
repeat the process.
Medtronic used the Prolystica™ family of cleaners according to the
manufacturer’s recommendations to validate the automated cleaning
process. It is the responsibility of the processor to ensure that the processing
is conducted in accordance with a validated method. Any deviation by the
processor from these recommendations should be evaluated.
1. Place the device in an automated washer (for example, Steris
Reliance™ Genfore™ Washer/Disinfector).
Note: Avoid contact between devices while loading the washer.
2. Set the automated washer to run the parameters identified in Table 3
and allow the automated washer to complete the wash cycle.
Table 3. Automated washer cleaning parameters
Treatment
Enzymatic
wash
Time
(min)
04:00 ≥60°C
Tempera-
ture Cleaning agent
Steris Prolystica™ Ultra Concen-
(≥140°F)
trate Enzymatic Cleaner diluted as
1.0 mL/1 L (or 0.125 ounce/1 gallon).
Wash 02:00 ≥60°C
(≥140°F)
Steris Prolystica™ Ultra Concentrate Neutral Detergent diluted as
1.0 mL/1 L (or 0.125 ounce/1 gallon).
6
Table 3. Automated washer cleaning parameters (continued)
Time
Treatment
(min)
Rinse 02:00 ≥60°C
Tempera-
ture Cleaning agent
N/A
(≥140°F)
Dry 15:00 ≥82°C
N/A
(≥180°F)
Inspection N/A N/A Visually inspect each device for
any remaining soil or moisture. If
soil remains, repeat the process. If
needed, dry the device with filtered, compressed air or a lint-free
wipe.
5.2 Steam sterilization and resterilization
• Use standard packaging material. Ensure that the pack is large enough to
contain the device without stressing the seals. When validating the
sterilization processes, Medtronic used the appropriate accessory tray
for each device.
• Medtronic validated steam cycles when the devices were wrapped by
CSR (Central Supply Room) wrap. However, the steam sterilization
process can be completed when the devices are either unwrapped or
wrapped in steam sterilization compatible materials.
• When sterilizing multiple devices in 1 autoclave cycle, do not exceed the
sterilizer’s maximum load.
• Examine the device for cracking or degradation prior to use. Do not use
the device if components show signs of cracking or degradation.
• Some non-US health care authorities recommend sterilization cycle
parameters that minimize the potential risk of transmitting
Creutzfeldt-Jakob Disease (CJD). This recommendation is especially
important for surgical instruments that could come into contact with the
central nervous system.
Table 4. Sterilization cycle parameters
Cycle type
Prevacuum
(dynamic-air-
removal)
Prevacuum
(dynamic-air-
removal)
Prevacuum (dynamic-
air-removal) for CJD
a
Temperature 132°C (270°F) 135°C (275°F) 134°C (273°F)
Exposure
4 min 3 min 18 min
time
Dry time
a
Medtronic recommends incinerating devices that have directly contacted patients
suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/CJD
diagnosis. NHS Estates HTM 2010 Parts 4 & 6: Appendix 2, Items contaminated with
TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform
Encephalopathies refer to a TSE decontamination cycle using a steam autoclave at a
temperature of 134°C to 137°C (273°F to 279°F) for a single cycle of 18 min or multiple
cycles totaling 18 min (for example, six 3 min cycles).
b
The minimum dry times were validated using sterilizers with vacuum drying capabilities.
Drying cycles using ambient atmospheric pressure may require longer dry times. Refer
to the sterilizer manufacturer’s recommendations.
b
20 min 16 min 30 min
6 Disclaimer of warranty (global)
ALTHOUGH THE PRODUCT HAS BEEN DESIGNED, MANUFACTURED,
AND TESTED PRIOR TO SALE UNDER CAREFULLY CONTROLLED
CONDITIONS, THE PRODUCT MAY FAIL TO PERFORM ITS INTENDED
FUNCTION FOR A VARIETY OF REASONS. MEDTRONIC HAS NO
CONTROL OVER THE CONDITIONS UNDER WHICH THIS PRODUCT IS
USED. THE WARNINGS CONTAINED IN THE PRODUCT LABELING
PROVIDE MORE DETAILED INFORMATION AND ARE CONSIDERED AN
INTEGRAL PART OF THIS DISCLAIMER OF WARRANTY. MEDTRONIC,
THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND
IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
7
FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE
LIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES
OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES
CAUSED BY ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE
PRODUCT, WHETHER THE CLAIM IS BASED UPON WARRANTY,
CONTRACT, TORT, OR OTHERWISE. EXCEPT AS OTHERWISE
AGREED TO IN WRITING BY AUTHORIZED MEDTRONIC PERSONNEL,
NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY
REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PRODUCT.
The exclusions and limitations set out above are not intended to, and should
not be construed so as to, contravene mandatory provisions of applicable law.
If any part or term of this Disclaimer of Warranty is held by any court of
competent jurisdiction to be illegal, unenforceable, or in conflict with
applicable law, the validity of the remaining portions of this Disclaimer of
Warranty shall not be affected, and all rights and obligations shall be
construed and enforced as if this Disclaimer of Warranty did not contain the
particular part or term held to be invalid.
8
Medtronic, Inc.
*M028268C001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
LifeLine Technical Support, 24-hour
consultation service:
1 877 526 7890
Canada
Medtronic Canada ULC
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
1 800 268 5346
© 2021 Medtronic
M028268C001 A
2021-11-30
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