奥林巴斯 STERRAD NX 灭菌器兼容性说明小直径柔性内镜、摄像头和附件-USB迷|专注于互联网分享

2024年3月17日发(作者：惠明知)

April 30, 2010

Re: Compatibility of Olympus Small Diameter Flexible Endoscopes, Camera Heads and

Accessories with the STERRAD

NX Sterilizer: Technical Information for Olympus

Customers in the United States

Dear Health Care Professional:

This letter provides information on the material and functional compatibility of Olympus small

diameter flexible endoscopes, camera heads and accessories with the STERRAD

NX Sterilizer

(STERRAD NX) manufactured by Advanced Sterilization Products (ASP), a Johnson & Johnson

Company.

OLYMPUS SMALL DIAMETER FLEXIBLE ENDOSCOPES

Olympus is announcing the compatibility of the listed Olympus small diameter flexible

endoscopes with STERRAD NX. Olympus flexible endoscopes that are compatible with STERRAD

NX are identified by the presence of a white line on the control section (see figure below). Olympus

flexible endoscopes that do not contain this identifying white line are NOT compatible with STERRAD

NX. If you are uncertain if an Olympus small diameter flexible endoscope is compatible with

STERRAD NX, please contact Olympus. Please note that the following statements apply only to

STERRAD NX. The products listed below are not compatible with STERRAD 100NX.

Compatible with limitation(s): The following statements apply only to Olympus small diameter

flexible endoscopes with a white line present on the control section. This white line indicates that the

device is compatible with STERRAD NX in accordance with the limitations stated below. Existing

Olympus endoscopes for the models listed below that do not have a white line present on the control

section are NOT compatible with STERRAD NX. Contact Olympus for information on upgrading

older endoscopes to be compatible with STERRAD NX.

OLYMPUS AMERICA INC.

3500 Corporate Parkway

P.O. Box 610

Center Valley, PA 18034-0610

Telephone: (484) 896-5000

Olympus has validated the material and functional compatibility of the listed Olympus endoscope

models with a white line present on the control section following a minimum of 100 cycles in the

STERRAD NX. Prior to 100 cycles in the STERRAD NX, cosmetic changes, such as discolorization

of black anodized aluminum parts, may be observed. Following 100 cycles in the STERRAD NX, the

listed models of Olympus small diameter flexible endoscopes with a white line on the control section

may require a bending section or insertion tube replacement.

•

BF-1T60

BF-MP60

BF-P60

BF-XP60

BF-MP160F

BF-XP160F

BF-1T180

BF-1TQ180

BF-P180

BF-Q180

•

BF-Q180-AC

CHF-P60

CYF-5

CYF-5A

CYF-V2

CYF-V2R

CYF-VA2

ENF-V2

ENF-VT2

ENF-VQ

•

LTF-V3

LTF-VP

LTF-VP-S

LTF-VH

LTF-160

MAF-GM

MAF-TM

URF-P5

URF-V

Materials of the flexible endoscope may be damaged or deteriorate after 100 cycles in the STERRAD

NX. Olympus testing indicates that the adhesive around the distal end lens and bending section, the

bending section cover, the coating of the insertion tube and universal cord, and the insertion tube itself

may be damaged or deteriorate after 100 cycles in the STERRAD NX. Damage or deterioration from

STERRAD NX reprocessing may add to preexisting damage/wear from prior use, accelerating the need

for endoscope maintenance. Inspect the device according to the instructions provided in the Endoscope

Manual prior to each use with specific attention to the materials listed above. Below are representative

examples of material damage that may be observed after 100 cycles. If any damage or deterioration of

the endoscope is observed, discontinue use of the endoscope and send it to Olympus for inspection and

repair. Use of a damaged endoscope may pose a risk to patient safety.

Deterioration of adhesive

around distal end lens

Bubbling of adhesive at

bending section cover

Cracking of bending

section cover