Genesis Sterilization Container System Accessories Instructions

Catalog Numbers

Cautions

All Genesis baskets, organizational accessories, and single use accessories supplied by CareFusion, V.Mueller Products and Services covered by these instructions for use are listed in the appendix. These instructions for use do not provide a complete guide for sterilization and cleaning of the Genesis reusable rigid container system. See the Genesis Sterilization Container Operators Manual for additional detail.

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 these accessories. Prior to use, all accessories should be inspected to ensure proper function and condition. Do not use accessories if they do not satisfactorily perform their intended function or have physical damage.

Intended Use The Genesis reusable rigid container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used.

Only one DST-series filter sheet, or thickness, should be used underneath each retention plate per process. Using more than one thickness or sheet of the filter has not been validated for efficacy.

Baskets and organizational accessories are intended to organize and secure medical devices during sterilization, transport, and storage of the container. Single use accessories, including the DST-series filter sheets, tamper-evident arrows, and data cards are intended to be used with the Genesis reusable rigid container systems and aid in sterilization processing and storage. Refer to the Genesis Sterilization Container Operators Manual for complete details on assembly, use and processing.

Sterilizers vary in design and performance characteristics. It is strongly recommended that the user verify the cycle parameters for the specific sterilizer prior to use. Adjusted cycle times may be required to properly sterilize desired loads. The accessories listed in the appendix have only been validated for use with Genesis reusable rigid container systems using the parameters defined in the Genesis Sterilization Container Operators Manual. If Instruction for Use are needed, contact your local V. Mueller representative or distributor or call the customer service center at 800.227.3220.

How Supplied Baskets, organizational accessories, and single use accessories are packaged as non-sterile. Baskets and organizational accessories must undergo cleaning prior to use.

Pre-processing Instructions Refer to the Genesis Sterilization Container Operators Manual for complete pre-processing and assembly instructions.

Limitations on Reprocessing Repeated processing has minimal effect on the baskets and organizational accessories. End of life is normally determined by wear and damage due to use. Single use accessories must be discarded after each process.

Select appropriate size filter according to the retention plate size. Each sterilant access (perforated) area requires one filter. The sterilant access area(s) is located in the container lids and in the bottoms of select container devices. Prior to insertion, inspect each filter to ensure it is free of any holes, tears or punctures which could adversely affect its performance.

Warnings Baskets, organizational accessories, and single use accessories shall be used in accordance with these instructions and the Genesis Sterilization Container Operators Manual. Read all sections of this insert prior to use. Improper use of these accessories may result in a non-sterile set after processing. In addition, improper care and maintenance of these accessories may render the accessories non-sterile prior to patient use and may cause serious injury to patient or healthcare provider.

Select appropriate tamper-evident arrow according to intended sterilization modality. White tamper-evident arrows are intended for steam modalities, yellow for Ethylene Oxide, and pink (fuchsia) for STERRAD 50 and 100S.

Manual and Automatic Cleaning Refer to the Genesis Sterilization Container Operators Manual for complete cleaning instructions and parameters compatible with the baskets and organizational accessories.

Do not use filter materials in the presence of flammable anesthesia. A safety hazard may be created. Filter materials other than the Genesis DST-series filters have not been validated for use with the Genesis reusable rigid containers. Follow the Modality Specific Recommendations for Accessories and Containers found in the Genesis Sterilization Container Operators Manual for determining proper container system setup and validated processing methods and parameters.

1

Inspection/Maintenance

Warranty

The Genesis accessories should be routinely inspected for damage which could result in the product not functioning as intended. Baskets and organizational accessories should be inspected for dents, sharp edges/corners, and proper function to ensure they are in good working order prior to use. Filters should be inspected for tears, punctures, and creases/folds which could adversely affect performance. Tamper-evident arrows should be inspected to ensure the chemical indicator dot has not undergone a premature color change.

Genesis baskets and organizational accessories are warranted for their lifetime to be free of functional defects in both materials and workmanship when used normally for their intended purpose of securing and organizing surgical instruments in the Genesis reusable rigid container systems. Any Genesis accessory proving to be so defective will be repaired or replaced at no charge.

Arrow

Pre-Process Dot Color

Post-Process Dot Color

White - Steam

White

Dark Gray or Black

Yellow Ethylene Oxide

Blue

Green

Pink (fuchsia) STERRAD

Yellow

Blue

Repairs or modifications performed by unauthorized personnel may void all product warranties and could affect performance and efficacy of device.

Repair Service Authorization is required before returning any item for Credit, Repair or Warranty replacement. Please contact your local V. Mueller representative or distributor or call the customer service center at 800.227.3220 for a Return Goods Authorization number. IMPORTANT: All devices being returned for maintenance, repair, etc. must be cleaned and sterilized per these instructions for use prior to shipment.

The degree of color change is not significant, as this color change is not an indication of sterility but that the process indicator dot (reactive chemical applied to the dot) has been exposed to specific sterilization parameters.

Pack goods securely to avoid damage during shipment. When shipping multiple products in one carton, avoid metal-to-metal contact. New product that has not been processed or sterilized may be returned for credit within 90 days of invoice date. Determination of credit amount or warranty repair/replacement will be made at the Genesis facility.

Packaging Only Genesis filters, tamper-evident arrows, data cards, baskets, organizational accessories and repair parts are validated for use with the Genesis reusable rigid sterilization container systems. Do not use unauthorized single use accessories or container products with the Genesis reusable rigid sterilization container system.

Do not use foam peanuts, newspaper or inflatable air packs. If you are in need of proper shipping material, contact your local V. Mueller representative or distributor or call the customer service center at 800.227.3220. Parts that are faulty due to defects in material or workmanship will be repaired or replaced at no charge. Parts that have been misused or mishandled are not covered under warranty. Used or processed items may not be returned for credit.

Sterilization Genesis reusable rigid sterilization container systems have been validated for use in Pre-Vacuum Steam, Gravity Displacement Steam, 100% Ethylene Oxide, and STERRAD 50 and 100S sterilizers. Refer to the Genesis Sterilization Container Operators Manual for proper assembly and sterilization of the Genesis reusable rigid container systems and accessories.

Contact Information: Contact your local V. Mueller representative or distributor or call the customer service center at 800.227.3220 with any questions or requests for additional information pertaining to your Genesis reusable rigid sterilization container system or accessories.

The same filter material (DST-series) has been validated for use in steam, 100% Ethylene Oxide, and STERRAD 50 and 100S sterilization modalities.

Storage When properly processed, Genesis reusable rigid sterilization container systems and validated accessories can be stored for up to 180 days. Refer to the Genesis Sterilization Container Operators Manual for additional information.

Other Resources: For additional information and detailed instructions on use, assembly and processing, refer to the Genesis Sterilization Container Operators Manual.

2

Appendix

Organizational Accessories

Baskets

DIN05-6237 DIN05-6238 DIN2087

DIN2088

DIN2089

DINGR1894 DP1-1

DP1-2

DP1-3

DP1-4

DP1-5

BP0-1A

BP0-2A

BP0-2V

BPS0-2A BP1-1AS

BP1-2A

BP1-2AS BP1-2V

BP1-2VS BP1-3A

GR1807

GR1808-1

GR1808-3

GR1808-4

BP1-3V

BP1-4A

BP1-4V

BPS1-2A BPS1-3A

GR1808-5

GR1808-6

GR1808-7

GR1808-8

BPS1-4A BP2-1AS BP2-2A

BP2-2AS BP2-2V

GR1808-9

GR1892-1

GR1892-10 GR1892-11

BP2-2VS BP2-3A

BP2-4A

GR1892-12 GR1892-2

GR1892-3

GR1892-4

GR1892-5

GR1892-6

GR1892-7

GR1892-8

GR1892-9

GR1893-1

GR1893-2

GR1893-3

BP2-5A

BP2-6A

BP2-3V BP2-6V

BP2-4V

BPS2-2A BPS2-3A

BPS2-4A BPS2-6A BP3-1AS BP3-2A

BP3-2AS

BP3-2V

BP3-2VS BP3-3A

BP3-3V

BP3-4A

BP3-4V

BP3-5A

BP3-5V

GR33322338 GR33322561 GR5300

GR5301

GR5302

GR5310

GR5311

GR5312

BPS3-2A BPS3-3A

GR5320

GR5330

GR5331

GR5332

BPS3-4A BPS3-5A BP4-2A

BP4-2AS BP4-2V

GR5333

GR5334

GR5335

GR5339

BP4-2VS BP4-4A

BP4-4V

BPS4-2A BPS4-4A

GR5340

GR5341

GR5350

GR5351

BP5-2AS BP5-2V

BP5-2VS BP5-3V

GR5352

GR5353

GR5354

GR5355

GR5370

GR5371

GR5372

GR5373

GR5374

GR5375

LP3-1

LP7-1

LP7-2

PP1-1

PP1-2

PP1-2.5

PP1-3

PP1-4

BP5-2A BP5-4A BP6-4V

BP5-4V

BPS5-2A BPS5-4A BP6-4A

BPS6-4A BP7-2AS BP7-3A

BP7-4A

BP7-4AS DINBP1-2A DINBP1-3A

DINBP1-4A

DINBP1-3V DINBP1-4V

DINBP1-2AS DINBP1-2VS

SX2-0

SX2-1

SX2-2

SX2-3

DINBP2-2A DINBP2-3A

DINBP2-4A

SX2-5

SX2-6

SX2972-1

SX2972-2

DINBP2-3V DINBP2-4V

DINBP2-2AS DINBP2-2VS

SX2972-3

SX2972-4

SX2972-5

SX2972-6

DINBP3-2A DINBP3-3A

DINBP3-4A

TB1-1

TB1-10

TB1-12

TB1-2

TB1-3

TB1-4

TB1-5

TB1-6

TB1-7

TB1-8

TB1-9

TB2-1

TB2-10

TB2-12

TB2-2

TB2-3

TB2-4

TB2-5

TB2-6

TB2-7

TB2-8

TB2-9

TB3-1

TB3-10

TB3-12

TB3-2

TB3-3

TB3-4

TB3-5

TB3-6

TB3-7

TB3-8

TB3-9

TB5-1

TC2-1

TC2-10

TC2-12

TC2-2

TC2-3

TC2-4

TC2-5

TC2-6

TC2-7

TC2-8

DINBP3-3V DINBP3-4V

DINBP1-2V

R-ALG00001 R-ALG00002 R-ALG00003 R-ALG00004

DINBP2-2V

DINBP3-2V

DINBP3-2AS DINBP3-2VS

TC2-9

3

Single Use Accessories AG2-1

AH2-1

AS2-2

AS2-3

R1792-A R1793-A R1794-A R1795-A R1796-A

DST-1 DST-2 DST-3 Replacement Parts

AG2-2

MD1-1

MH1-1

R1797-A R1798

R1004

R1039

R1041

R1043

R1046

R1828

R1047

R1063

R1072

R1073

R1074

R1841-A R1842-A R1843-A R1844

R1845

R1120

R1122

R1123

R1124

R1125

R1846

R1849

R1850

R1851

R1853

R1133

R1134

R1135

R1136

R1137

R1861

R1876

R1885

R1926

R1927

R1138

R1139

R1140

R1141

R1142

R1928

R1929

R1930

R1932

R1933

R1151

R1152

R1157

R1170

R1171

R1938-1 R1938-10 R1938-12 R1938-2 R1938-3

R1177

R1178

R1179

R1184

R1187

R1938-4 R1938-5 R1938-6 R1938-7 R1938-8

R1188

R1189

R1190

R1191

R1220

R1938-9 R1941

R1942

R1943

R1944

R1221

R1222

R1223

R1224

R1225

R1945

R1946

R1947

R1948

R1953

R1226

R1322

R1381

R1382

R1383

R1954

R1955

R1956

R1961

R1965

R1384

R1388

R1389

R1394

R1395

R1966

R1966ST R1967

R1968

R1968ST

R1413

R1415

R1502

R1512

R1514

R1969

R1970

R1522

R1542

R1589

R1590

R1591

R1972ST R1973

R1592

R1594

R1595

R1596

R1597

R1976

R1976ST R1977

R1621

R1623

R1624

R1626

R1645

R1979

R1980

R1671

R1672

R1693

R1694

R1695

R1982ST R1983

R1698

R1699

R1704

R1705

R1706

R1986

R1988

R1989

R1707

R1708

R1709

R1710

R1711

R2009-1 R2014

R2015

R2016

R2052

R1712

R1713

R1714

R1715

R1716

R2053

R2054

R2055

R2056

R2057

R1717

R1718

R1719

R1720

R1721

R2058

R2059

R2060

R2061

R2062

R1722

R1723

R1724

R1725

R1726

R2063

R2064

R2065

R2066

R2067

R1727

R1765

R1766

R1767

R1768

R2068

R2069

R2070

R2071

R2072

R1769

R1770

R1773

R1774

R1775

R2073

R2074

R2075

R2076

R2077

R1776

R1777

R1778

R1779

R1780

R2078

R2079

R2080

R2083

R2084

R1781

R1782

R1783

R1784

R1785

R2085

R2086

RP30-2

RP40-1

RP50-1

R1786

R1787

R1788

R1790-A R1791-A

R1827-1 R1827-2 R1827-3

R1827-4 R1827-5 R1827-6 R1827-7 R1827-8

RP50-2

4

R1829

R1831

R1832

R1970ST R1971 R1974

R1986ST R1987

R1972

R1974ST R1975 R1978

R1980ST R1981 R1984

R1840-A

R1978ST R1982

R1984ST R1985