SterilContainer S

The SterilContainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 60 Low Temperature Sterilization System’s Lumen, Non Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

The SterilContainer S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization.

V-PRO 60 Sterilizer Lumen Cycle

Total

Lid Bottom Description load.e d Intended Container Load

container

weight (1bs)

JM440 Full Size 90mm (4 %")* 21.46 [ Lumened and non-lumened devices with

: —— diffusion-restricted spaces such as the hinged

JM489 | IM441 Full Size 120mm (5 A7) 21.46 portion of forceps and scissors

IM442 Full Size 135mm (6)* 21.46 e Medical devices, including single, dual and

: = triple channeled rigid and semi-rigid

_IM740 % Size 90mm (4 14”)* 13.85 endoscopes, with the following configurations:

IM789 | IM741 % Size 120mm (5 47)* 13.85 e single or dual lumen devices with stainless

= lumen(s) that is (are} > 0.77 mm internal

IM742 % Size 135mm (67)* 13.85 ~ diameter (ID) and < 410 mm length

IM340 ¥ Size 90mm (4 %")* 13.85 s triple lumen devices with stainless steel

lumens that are

IM389 | JM341 Y% Size 120mm (5 '47)* 13.85 > [.2 mm ID and < 275 mm length

IM342 % Size 135mm (67)* 13.85 2 1.8 mmID and <310 mm length

L one Mini 73 > 2.8 mm ID and <317 mm length

Mo20 | mo21 | FX OFE,)*T' mm 7.65

o]

Mini 67mm

IM174 1 ] -

MI188 (2 9y 7.65

* The validation chamber load consisted of one container containing a basket and basket Iid, mat, accessories, 12 lumens, and

metal and non-metal medical devices

**The validation chamber load consisted of two containers containing a basket and basket lid, mat, accessories, and metal

and non-metal medical devices for a total chamber load weight of 15.30 1bs. Each container held six (6) lumens for a total of

12 total lumens per load.

V-PRO 60 Sterilizer Non Lumen Cyele

Total

Lid Bottom Description 1oad'e d Intended Container Load

container

weight (Ibs)

IM440 Full Size 90mm (4 Y47)* 20.0

IM489 44T | Full Size 120mm (5 %)% 200

IM442 Full Size 135mm (6™)* 20.0

IM740 ¥ Size 90mm (4 Y47)* 13.85 Non-lumened devices including

IM789 miv7a1 % Size 120mm (5 %) 13.85 devices with stainless steel or

IM742 % Size 135mm (6™)* 13.85 titanium diffusion-restricted spaces

IM340 ¥ Size 90mm (4 %7)* 13.85 such as the hinged portion of forceps

IM389 V1341 % Size 120mm (5 V&7)* 13.85 and scissors.

IM342 Y, Size 135mm (67)* 13.85

IMO020 | JMO021 Extra Long Mini 73mm (37)** 7.64

IM174 | IM188 Mini 67mm (2 %”)** 7.64

* The validation chamber load consisted of one container with a basket and basket lid, mat, accessories, and metal and non-

metal medical devices

**The validation chamber load consisted of two containers with a basket and basket lid, mat, accessories, and metal and non-

metal medical devices for a total chamber load weight of 15.30 Ibs.

V-PRO 60 Sterilizer Flexible Cycle

Total

loaded

Lid Bottom Description® container Intended Container Load

weight

(1bs)

IM440 | Full Size 90mm (4 '4™) 21.46 One flexible surgical endoscope or

M489 JM441 | Full Size 120mm (5 %7) 21.46 bronchoscope with a light cord (if not integral

to the endoscope) and mat without any

IM442 Full Size 135mm (6™) 21.46 | additional load. The flexible endoscopes may

IM740 % Size 90mm (4 14”) 13.85 contain:

IMT789 \TIN741 | % Size 120mm (5 %) 13.85 | e single or dual lumen devices with lumens

IM742 % Size 135mm (67) 13.85 that are > 1 mm ID and < 990 mm length

IM389 IN341 | v Size 120mm (5 %) 13.85

JM342 Y4 Size 135mm (67) 13.85

* The validation chamber load consisted of one container with a basket and lid, mat, accessories, three (3) 1 x 1000mm

lumens, one flexible endoscope, and one light cable.

V-PRO 60 Sterilizer Compatible SterilContainer S Accessories

Accessories Y-PRO 60

Stainless Steel baskets, Yes

basket lids, and dividers )

Instrument Organization Yes

System (Silicone and

Stainless Steel racks,

brackets, holders, and

clamps)

Silicone mats Yes

Stainless Steel racks, trays, Yes

holders, clamps, brackets

and platforms