Care Fusion Snowden-Pencer 89-0500 User manual

Diamond-Flex Graspers and
Dissectors
Pinces et dissecteurs
Diamond-Flex
Pinzas de agarre y Disectores
Diamond-Flex
Diamond-Flex グラスパー
とイセクター
Snowden-Pencer™
Rx Only
USA
Snowden-Pencer is a trademark and/
or registered trademark of CareFusion
Corporation, or one of its affiliates.
Contact Information
BD Customer Service
800-323-9088
For email inquiries:
[email protected]
For customers outside of the USA, please contact
your local distributor.
© 2011, 2013, 2017, 2020, CareFusion Corporation
or one of its affiliates. All rights reserved.
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en
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CareFusion
75 North Fairway Drive
Vernon Hills, IL 60061 USA
Australian and New Zealand Sponsors:
Becton Dickinson Pty. Ltd.
66 Waterloo Road
Macquarie Park, NSW 2113, Australia
Becton Dickinson Limited
14B George Bourke Drive
Mt. Wellington, Auckland, 1060 New Zealand
CF36-1807C / 26-8945-D • 2020-02
DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
Proofed by: _____________________________ Date:______________ Dimensions checked:________________ Copy checked: _____________

Figure, Image, Figur, 図
DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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1
Catalog Numbers: All product codes that are covered by
these instructions are listed in the appendix.
Device Components
(a) Handles
(b) 5.3mm shaft
(c) Flexible segments
(d) Jaws
(e) Sterilization sleeve (89-6119)
(f) Ratchet on/off lever
(g) Articulation knob
(h) Flush port
(i) Rotation knob
Indications For Use
Diamond-Flex™ Graspers and Dissectors are designed to
transmit grasping force through delicate working tips in
both minimally invasive and open surgical procedures.
How Supplied
Snowden-Pencer™ devices are packaged non-sterile.
Cleaning and sterilization must occur prior to use.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on these devices.
End of life is normally determined by wear and damage due
to use.
Warnings
Snowden-Pencer devices are to be used in accordance with
these instructions for use. Read all sections of this insert
prior to use. Improper use of the device may cause serious
injury. In addition, improper care and maintenance of the
device may render the device non-sterile prior to patient
use and cause a serious injury to the patient or health care
provider.
Cautions
If there are any variations between these instructions and
either your facility’s policies and/or your cleaning/sterilizing
equipment manufacturer’s instructions, those variations
should be brought to the attention of the appropriate
responsible hospital personnel for resolution before
proceeding with cleaning and sterilizing your devices.
Use of instrument for a task other than that for which it is
intended will usually result in a damaged or broken device.
Examples
1. Use of a delicate dissector as a grasper.
2. Use of a dissector to remove clips.
3. Use of a 5mm grasper or dissector instead of a 10mm
claw extractor forceps to remove excised tissue through
cannula.
Prior to use, inspect device to ensure proper function,
insulation and condition. Do not use devices if they do
not satisfactorily perform their intended function or have
physical damage.
Avoid mechanical shock or overstressing devices. Close
distal ends prior to insertion or removal through cannulas.
en

DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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Devices are designed to be held with one finger and thumb
in ring handles. If force applied in any other fashion (such
as holding handles in whole pistol grip), the mechanism
can be easily overstressed resulting in damage or breakage.
Only the cleaning and sterilization processes which
are defined within these instructions for use have been
validated.
Always use caution when inserting or removing
instruments through cannula. Lateral pressure on the
instrument during removal can damage the working tip,
shaft of the instrument and/or insulation. Be sure the tips
are closed and the instrument is pulled straight out until
completely clear of cannula to avoid catching the valve
assemblies in cannulas or dislodging the cannula.
Use only neutral pH (6-8) solutions.
Pre-processing Instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institutions established transport
procedure.
Remove excess gross soil as soon as possible after use by
rinsing or wiping the device.
All devices must be processed in the completely open
configuration.
All flush ports shall remain in the fully open position.
When sterilizing or storing this device, always use the
protective/sterilizing sleeve provided. Failure to use
the sleeve may result in premature device failure. This
device should never be folded or bent to fit into a small
sterilization tray.
Manual Cleaning
1. Ensure all pre-processing instructions are followed prior
to cleaning.
2. Prepare the enzymatic/neutral pH detergent solution,
utilizing tap water with a temperature range of 27°C to
44°C (81°F to 111°F), per manufacturer’s instructions.
3. Place device in the open/relaxed position, with flush
port open, and completely immerse in the detergent
solution and allow device to soak for a minimum of 5
minutes. Actuate all movable parts during the initiation
of the soak time.
4. Using a soft bristled brush, remove all visible soil
from the device. Actuate device while brushing, paying
particular attention to hinges, crevices and other
difficult to clean areas. Note: It is recommended that the
detergent solution is changed when it becomes grossly
contaminated (bloody and/or turbid).
5. For lumen devices, use a soft bristled brush with a
brush diameter and length that is equivalent to lumen
diameter and length. Scrub the lumen (i.e. angulated/
nonangulated positions) until no visible soil is detected
in the lumen rinsing step below.
6. For lumen devices, place the device into the open/
relaxed position with the distal tip pointed down. Flush
the device with a minimum of 50 ml of detergent
solution utilizing a temperature range of 27°C to 44°C
(81°F to 111°F), by using the flushing port located on
the handle/shaft. Repeat the flush process a minimum
of 2 times (i.e. total of 3 times) ensuring all fluid exiting
the lumen is clear of soil.

DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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7. For lumen devices, if visible soil is detected during the
final lumen flush, re-perform brushing and flushing of
the lumen.
8. Rinse the device by completely immersing in tap water
with a temperature range of 27°C to 44°C (81°F to
111°F), for a minimum of 30 seconds to remove any
residual detergent or debris.
9. For lumen devices, following the rinsing step, place the
device into the open/relaxed position with the distal tip
pointed down. Flush the device with a minimum of 50 ml
of tap water utilizing a temperature range of 27°C
to 44°C (81°F to 111°F), by using the flushing port
located on the handle/shaft. Repeat the flush process a
minimum of 2 times (i.e. total of 3 times).
10.Dry the device with a clean, lint-free towel.
11.For lumen devices, manipulate the device to allow rinse
water to drain from the lumen.
12.Visually examine each device for cleanliness.
13.If visible soil remains, repeat cleaning procedure.
Automatic Cleaning
Automatic Cleaning Process - Enzymatic/Neutral pH
Detergent
• Ensure all pre-processing instructions are followed prior to
cleaning.
• Clean the devices via the automatic cleaning parameters
below.
Phase Minimum Recirculation
Time
Water
Tempurature
Detergent Type
and Concentration
(If applicable)
Pre-Wash 15 Seconds
Cold Drinking
Water
1°C - 16°C
(33°F - 60°F)
N/A
Enzyme
Wash 1 Minute
Hot Drinking
Water
43°C - 82°C
(110°F - 179°F)
• Detergent:
pH-neutral/enzymatic
• Concentration:
Per the detergent
manufacturer’s
recommendations
Wash 2 Minutes
Hot Drinking
Water
43°C - 82°C
(110°F - 179°F)
• Detergent: pH-neutral
cleanser
• Concentration:
Per the detergent
manufacturer’s
recommendations
Rinse 15 Seconds
Hot Drinking
Water
43°C - 82°C
(110°F - 179°F)
N/A
Pure Rinse 10 Seconds
Treated Water
(Hot)
43°C - 82°C
(110°F - 179°F)
N/A
Drying N/A N/A N/A

DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
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• For lumen devices, manipulate the device to allow rinse
water to drain from the lumen.
• If visible moisture is present, dry the instrument with a
clean, lint free towel.
• Visually examine each instrument for cleanliness.
• If visible soil remains, repeat cleaning procedure until the
device is thoroughly clean.
Note: The final rinse step should be performed with treated
water: purified, deionized, distilled or reverse osmosis. If
drinking water is used as part of the final rinse, ensure
corrosion does not occur.
Inspection/Maintenance
Proper care and handling is essential for satisfactory
performance of any surgical device. The steps in these
instructions for use should be taken to ensure long and
trouble-free service from all your surgical devices. Inspect
devices before each use for broken, cracked, tarnished
surfaces, movement of hinges, and chipped or worn parts.
If any of these conditions appear, do not use the device.
Return device to authorized repair service center for repair
or replacement.
Before sterilizing, lubricate the device with instrument milk
or a steam permeable/water soluble lubricant, following the
lubricant manufacturer’s instructions. Check for smooth
action of all moving parts.
Let devices drip dry for (3) minutes before packaging for
sterilization.
Packaging
Devices can be loaded into dedicated packaging
systems. Sterilization wrap material must be cleared for
the applicable sterilization modality by your countries
regulatory body. Use in accordance with packaging
manufacturer’s sterilization instructions being sure to
protect jaws and cutting edges from damage.
Sterilization
All devices must be processed in the completely open
configuration.
IMPORTANT NOTICE: Diamond-Flex™ graspers and
dissectors must only be sterilized in the fully relaxed
(straight) position. Before sterilization, the ‘protective/
sterilization sleeve’ must be placed over the flexible,
segmented portion of the device shaft. Failure to follow
these instructions may significantly impair the life of the
graspers and dissectors.
All flush ports shall remain in the fully open position.
All devices shall be positioned to allow sterilant contact of
all surfaces.
All devices with concave surfaces shall be configured so
that water pooling does not occur.

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Parameters for Steam Sterilization (Autoclave)
Prevacuum Sterilization Cycle:
Minimum Preconditioning Pulses: 3
Minimum Exposure Temperature: 132°C (270°F)
Minimum Exposure Time: 3 Minutes
Minimum Dry Time: 30 Minutes
Sterilization Configuration: Individually wrapped
(1 layer-2ply or 2 layer-1ply)
Storage
Note: always store and sterilize the grasper in its
protective/sterilizing sleeve.
After sterilization, devices must remain in sterilization
packaging and be stored in a clean, dry environment.
Operating Instructions
See Figures 1 and 2 for descriptions of the device
components
Insertion
1. With the device in the straightened state, insert device
through cannula. (See Figures 3 and 4)
A. Always keep the tip of the device in the field of
endoscopic vision.
2. Articulate the graspers shape
A. Make sure the last segment has emerged through the
cannula before articulating the graspers.
B. Squeeze the handles together to flex the distal tip and
hold the tension. (See Figure 5)
C. Rotate the tension knob fully clockwise until it is
finger tight to lock in the shape. (See Figure 6)
D. Open and close the handles to actuate the jaws.
E. To operate the optional ratchet mechanism, pivot the
ratchet lever to the right.
360° Jaw Rotation
3. Push 360° shaft rotation knob forward (away from the
handle). (See Figure 7)
4. Rotate knob and hence the jaws until they are in the
desired orientation. (See Figure 8)
5. Release 360° knob to lock the jaws into position.
Removal
1. Straighten graspers shape
A. Squeeze the handles together and hold the tension.
(See Figure 9)
B. Rotate the tension knob fully counter-clockwise.
(See Figure 10)
C. Release the tension on the handles to allow the jaw
segments to relax.
2. Slowly withdraw through the cannula. If there is
resistance to this motion, rotate the device during
withdrawal. (See Figure 11)

DCN 45345 CF36-1807C 13FEB2020 David Knuth Vernon Hills, IL
Proofed by: _____________________________ Date:______________ Dimensions checked:________________ Copy checked: _____________
6
Warranty
CareFusion guarantees every surgical device bearing the
Snowden-Pencer brand name to be free of functional
defects in workmanship and materials when used normally
for its intended surgical purpose. Any Snowden-Pencer
device proving to be defective will be replaced or repaired
at no charge. This device carries a lifetime warranty against
manufacturer defects and a 1 year warranty against wear.
Repair Service
Regardless of age, if any V. Mueller or Snowden-Pencer
device needs repair, contact customer service to facilitate
shipping to an authorized service center.
For repairs outside the U.S., please contact your local
distributor.
Note: All devices being returned for maintenance, repair,
etc. must be cleaned and sterilized per these instructions
for use prior to shipment.
Contact Information
BD Customer Service
800-323-9088
For email inquiries:
[email protected]
Other Resources: To learn more about sterilization
practices and what is required of manufacturers and end
users, visit www.aami.org, www.aorn.org or www.iso.org.