Mizuho LawtonElite Atraumatic Malleable Suctions Instructions For Use

MES-CK07-871-01EN-0
PREPARED: (2021-12-14) (Version 1)
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Trade Name: LawtonElite Atraumatic Malleable Suctions

Warning

1. Please read these instructions carefully prior to using this product.
Product should be used according to these instructions, and pay
close attention to the safety of patients.
Manufacturer's recommendations may cause harm or injury to the
patient.
For the US market
Do not reuse the device when it is used on a patient with or
suspected of having Creutzfeldt-Jakob Disease (CJD) or variant CJD
(vCJD).
For the market outside the US
When the device is used on a patient with or suspected of having
CJD or vCJD, make sure to adhere to the most recent and updated
restrictions available in each country and/or region for its reuse. Be
cautious of the possibility of secondary infection. Refer to
www.a-k-i.org or AAMI Standard ST79 for more information related
to cleaning and sterilization.
2．Do not bend any more than 30° at 1 point.
[Broken or damaged pieces may remain in the body making it
impossible to insert a mandolin.]
3．Refrain from topical bending and repeated bending at the same
location.
[Broken or damaged pieces may remain in the body.]
4．Do not bend at the tip and base of pipe.
[Broken or damaged pieces may remain in the body.]

Contraindication/Prohibition

1. Use for intended purpose only
Use devices for their intended purposes only. Incorrect use could
cause this product to break.
2. Prohibition of secondary processing of this product
Do not apply any secondary processing to this product. For example,
do not apply impacts or vibration markings to the surface of this
product. Doing so could break this product.
Symbol mark for labeling
MD : Medical Device

Specifications

Shape
In combination
Main body of suction tube
Mandolin
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Instruction for Use
Failure to follow
Code No.
LawtonElite Atraumatic Malleable Suction Tube 7.5 cm
07-871-01
WL, 3Fr
LawtonElite Atraumatic Malleable Suction Tube 7.5 cm
07-871-02
WL, 5Fr
LawtonElite Atraumatic Malleable Suction Tube 7.5 cm
07-871-03
WL, 7Fr
LawtonElite Atraumatic Malleable Suction Tube 7.5 cm
07-871-04
WL, 9Fr
LawtonElite Atraumatic Malleable Suction Tube 9.5 cm
07-871-05
WL, 3Fr
LawtonElite Atraumatic Malleable Suction Tube 9.5 cm
07-871-06
WL, 5Fr
LawtonElite Atraumatic Malleable Suction Tube 9.5 cm
07-871-07
WL, 7Fr
LawtonElite Atraumatic Malleable Suction Tube 9.5 cm
07-871-08
WL, 9Fr
LawtonElite Atraumatic Malleable Suction Tube 11.5 cm
07-871-09
WL, 3Fr
LawtonElite Atraumatic Malleable Suction Tube 11.5 cm
07-871-10
WL, 5Fr
LawtonElite Atraumatic Malleable Suction Tube 11.5 cm
07-871-11
WL, 7Fr
LawtonElite Atraumatic Malleable Suction Tube 11.5 cm
07-871-12
WL, 9Fr
Material: Stainless Steel

Intended purpose

This product is a device connected with the suction device during
operation or treatment to control or instruct suction. This product is a
reusable universal suction tip.

Intended user

This product is to be used by health care professionals, including but not
limited to surgeons, nurses and biomedical technicians.
Instructions for use
・Before using this product, inspect, wash, and sterilize in accordance
with these instructions.
・Bend the pipe manually.
・Inspect the instruments for damage and cracks prior to and after use.
(Refer to Maintenance / Inspection)

Warning/Caution

1．Important fundamental cautions
Prior to use the device must be sterilized under the standard
Sterilization conditions or the validated sterilization conditions for
which validity has been proven by medical organizations in each
country or region.
2．Defect/Adverse event
Defect
・Corrosion or pitting caused by use of chemicals
・Damage or breakage caused by the corrosion or pitting
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Product Description