Summit Medical Instrucsafe User manual

www.instrusafe.com
®
AN
INNOVIA
MEDICAL
COMPANY
INSTRUMENT PROTECTION SYSTEMS
SYSTÈMES DE PROTECTION DES INSTRUMENTS
INSTRUMENTENSCHUTZSYSTEME
SISTEMAS DE PROTECCIÓN DE INSTRUMENTAL
SISTEMAS DE PROTEÇÃO DE INSTRUMENTOS
SISTEMI DI PROTEZIONE PER STRUMENTI
医療器具プロテクションシステム
INSTRUCTIONS FOR USE: English
MODE D’EMPLOI: Français
GEBRAUCHSANWEISUNG: Deutsch
INSTRUCCIONES DE USO: Español
INSTRUÇÕES DE UTILIZAÇÃO: Português
ISTRUZIONI PER L’USO: Italiano
取扱説明書: 日本語

TABLE OF CONTENTS | ENGLISH
SUBJECT PAGE
Read First
Indications for Use 1
Device Description 1
Sterilization Methods and Configurations 1-2
Limitations 2-3
Warnings 4
Universal Precautions 4
Points of Use 4
Cleaning 4
Disinfection 4
Maintenance, Inspection and Testing 4
Parts 5
Assembly 6
Packaging 7
Sterilization 8
Storage 8
Warranty 9
Appendix A 64-71
ÍNDICE | ESPAÑOL
TEMA PÁGINA
Lea primero esta sección
Indicaciones de uso 28
Descripción del dispositivo 28
Métodos y configuraciones de esterilización 28-29
Limitaciones 29-30
Advertencias 31
Precauciones universales 31
Puntos de uso 31
Limpieza 31
Desinfección 31
Mantenimiento, inspección y pruebas 31
Partes 32
Montaje 33
Embalaje 34
Esterilización 35
Almacenamiento 35
Garantía 36
Apéndice A 64-71
 
 

 55
 55
 5556
 5657
 58
 58
 58
 58
 58
 58
 59
 60
 61
 62
 62
 63
 A 64-71
TABLE DES MATIÈRES | FRANÇAIS
SUJET PAGE
À lire avant la mise en service
Indications 10
Description du dispositif 10
Méthodes de stérilisation et configurations 10-11
Limites 11-12
Avertissements 13
Précautions universelles 13
Points d’utilisation 13
Nettoyage 13
Désinfection 13
Maintenance, inspection et tests 13
Pièces 14
Assemblage 15
Emballage 16
Stérilisation 17
Stockage 17
Garantie 18
Annexe A 64-71
ÍNDICE | PORTUGUÊS
ASSUNTO PÁGINA
Ler em primeiro lugar
Indicações de utilização 37
Descrição do dispositivo 37
Métodos de esterilização e configurações 37-38
Limitações 38-39
Advertências 40
Precauções universais 40
Pontos de utilização 40
Limpeza 40
Desinfeção 40
Manutenção, inspeção e testes 40
Peças 41
Montagem 42
Embalagem 43
Esterilização 44
Armazenamento 44
Garantia 45
Anexo A 64-71
INHALTSVERZEICHNIS | DEUTSCH
THEMA SEITE
Vorab lesen
Indikationen 19
Beschreibung des Geräts 19
Sterilisationsmethoden und Konfigurationen 19-20
Einschränkungen 20-21
Warnhinweise 22
Allgemeine Vorsichtsmaßnahmen 22
Einsatzort 22
Reinigung 22
Desinfektion 22
Wartung, Inspektion und Prüfung 22
Teile 23
Montieren des Gries 24
Verpackung 25
Sterilisation 26
Lagerung 26
Garantie 27
Anhang A 64-71
INDICE | ITALIANO
SEZIONE PAGINA
Informazioni importanti
Indicazioni per l’uso 46
Descrizione del dispositivo 46
Metodi di sterilizzazione e configurazioni 46-47
Limiti 47-48
Avvertenze 49
Precauzioni universali 49
Punto di utilizzo 49
Pulizia 49
Disinfezione 49
Manutenzione, ispezione e test 49
Parti 50
Assemblaggio 51
Confezionamento 52
Sterilizzazione 53
Conservazione 53
Garanzia 54
Appendice A 64-71

1
Summit Cassette Model AesculapContainer Model
IN-8823-AE *JN444
IN-2880 *JK444
IN-6105 *JN742
The instructions provided within have been validated by the device manufacturer as being capable of
reprocessing reusable medical devices.
Individual sterilizers, instrument cleanliness, specific loading of instrument trays, types and geometry of
instruments, sterilization containers, filters and wrappings vary at each location.
READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE
INDICATIONS FOR USE
InstruSafeInstrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a
healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical
devices during these sterilization cycles:
• pre-vacuum steam • STERRAD100NXExpress
• ethylene oxide • STERRAD100NXFlex
• STERRAD100S Standard • STERRADNXStandard
• STERRAD100NXStandard • STERISAMSCOV-PRO, V-PRO 1 and V-PRO maX
The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap, Aesculap®
rigid container or Genesis™ rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to
maintain sterility. A full list of device models is provided in Appendix A.
Device Description:
Summit Medical InstruSafe Instrument Protection Systems are cassettes/trays used to enclose and hold surgical instruments and
instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The
cassettes/trays do not have direct patient contact. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are
dierent sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes/trays have perforations to allow
sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical
instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.
Sterilization Methods and Configurations:
The following sterilization trays were validated with the corresponding rigid containers:
» Ethylene Oxide (EO):
Preconditioning Parameters:
Temperature: 131°F (55°C)
Relative Humidity: 70 ± 15%
Time: 1 hour
Sterilization Parameter:
Temperature: 131°F (55°C)
Minimum Exposure Time: 120 minutes
Minimum Aeration Time: 12 hours
*Validated by Summit Medical for use in steam prevacuum sterilizers
ONLY operating at 270°F (132°C) for 4 minutes exposure time.
Consult container instructions to ensure that contents do not exceed
the sterilization containers intended load claims.
*Validated by Summit Medical for use in ethylene oxide sterilizers
ONLY operating at 131°F (55°C). Consult container instructions to
ensure that contents do not exceed the sterilization containers
intended load claims.
» STERRAD100S Standard Cycle:
*Validated by Summit Medical for use in STERRAD 100S Standard
Cycle ONLY. Consult container instructions to ensure that contents
do not exceed the sterilization containers intended load claims.
» Autoclave Sterilization Parameter:
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Summit Cassette Model Genesis™ Container Model
IN-2681 *CD2-10-CDL
IN-0000 *CD2-10-CDL
IN-8613 *CD2-10-CDL
IN-6105 *CD2-10-CDL
Summit Cassette Model Genesis™ Container Model
IN-8823 *CD3-9CDL
IN-2880 *CD6-6C
IN-6105 *CD5-61C
Summit Cassette Model AesculapContainer Model
IN-8823-AE *JM444
IN-6105 *JM440

2
» STERRADNXStandard Cycle:
Note: The worst case validated load based on vent-to-volume
calculation is the IN-2681 tray.
» STERRAD100NXStandard Cycle:
*Validated by Summit Medical for use in STERRAD 100NX Standard
Cycle ONLY. Consult container instructions to ensure that contents
do not exceed the sterilization containers intended load claims.
Note: The worst case validated load based on vent-to-volume
calculation is the IN-2681 tray. The worst case validated load
based on the number of instruments and estimated weight is
the IN-8823-XX tray.
» STERRAD100NXExpress Cycle:
This cycle is not validated for use in rigid containers.
» STERRAD100NX Flex Cycle:
*Validated by Summit Medical for use in STERRAD 100NX Flex Cycle
ONLY. Consult container instructions to ensure that contents do not
exceed the sterilization containers intended load claims.
Note: The worst case validated load based on vent-to-volume
calculation is the IN-0000 tray.
» STERISAMSCOV-PRO: Low Temperature Sterilization Systems:
*Validated by Summit Medical for use in STERIS AMSCO V-PRO Low
Temperature Sterilization Systems ONLY. When using the Aesculap
container as a sterile barrier, the load (Summit Tray and contents),
should not exceed the load claims for the container in weight or load
type.
Note: The worst case validated load based on vent-to-volume
calculation is the IN-2681 tray.
Sterilization Methods and Configurations: (continued)
LIMITATION ON PROCESSING
1. The end of useful life on the InstruSafe Instrument Protection System is a minimum of 25 sterilization cycles. Inspect the tray
before use for wear and damage caused by use and discontinue use if visible signs of wear are present including corrosion,
mechanical failures, cracking, peeling, flaking, broken welds, damaged feet, damaged latches, damaged Hold-It/Hold-Down,
discoloration, etc.
2. See Table 2 for sterilization methods and configurations.
3. DO NOT OVERLOAD InstruSafe Systems or components, see the maximum weight chart in Appendix A.
4. DO NOT OVERLOAD individual Hold-It slots. Load only one instrument per Hold-It slot. For Hold-It table visit www.instrusafe.
com Resources page.
5. For rigid container users, DO NOT WRAP InstruSafe Systems or components and place inside of container for
sterilization.
6. Inside of sterilizers, DO NOT STACK individually wrapped or containerized InstruSafe Systems or components. Separate
wrapped or containerized InstruSafe Systems or components from each other or any other items on separate shelves of the
sterilizer to allow for maximum sterilant flow.
7. The use of non absorbent tray liners (i.e. silicone fingered organizing mat) can cause condensate to pool. If visible moisture is
present, re-sterilize with a longer dry time.
Summit Cassette Model AesculapContainer Model
IN-0000 *JM440
IN-6105 *JM440 Summit Cassette Model AesculapContainer Model
IN-8823 *JM444
IN-6105 *JM742
Sterilizer Standard
Cycle
Lumen
Cycle
Non Lumen
Cycle
V-PRO 1 X N/A N/A
V-PRO 1 PLUS N/A X X
V-PRO maX N/A X X
Summit Cassette Model AesculapContainer Model
IN-2681 *JM441
IN-8987-S *JM441
IN-8615 *JM441
IN-6105 *JM441
Summit Cassette Model AesculapContainer Model
IN-8823-AE *JM444
IN-6105 *JM440

3
LIMITATION ON PROCESSING (continued)
8. Lumen size of instrumentation validated includes:
Lumen claims for pre-vacuum steam:
Lumen claims for STERRAD100S Standard and
STERRAD 100NXStandard Cycles:
9. The total weight of the container system (e.g. container, tray and instrument load) must not exceed 25 pounds.
10. Complex instruments (eg., endoscopes, and instruments with lumens or channels) should be prepared and sterilized
according to the instrument manufacturer’s instructions.
Lumen claims for STERRAD100NXFlex Cycle:
Lumen claims for STERISAMSCOV-PRO:
Lumen claims for STERRADNXStandard Cycle:
Note: The InstruSafe Instrument Protection System has no lumen claims
for the STERRAD 100NX Express Cycle.
Summit Cassette Model
Minimum
Inside
Diameter
Maximum
Length
Number of
Lumens
IN-8823-CF 3mm 400mm 4
IN-8823-CF 3mm 200mm 2
IN-2880 1mm 76mm 2
IN-2880 3mm 177mm 1
IN-6105 5mm 241mm 1
IN-2681 1mm 65mm 1
IN-2681 3mm 200mm 1
IN-7823 1mm 400mm 17
IN-0000
1mm 400mm 5
3mm 400mm 1
5mm 400mm 1
Summit
Cassette
Model
Minimum
Inside
Diameter
Maximum
Length
Number
of
Lumens
Wrap/Rigid
Container
IN-0000 1mm 850mm 1 Wrap + Rigid
IN-8823 1mm 850mm 1 Wrap + Rigid
IN-7344 1mm 850mm 1 Wrap
IN-6105 4mm 235mm 1 Wrap + Rigid
Summit Cassette Model
Minimum
Inside
Diameter
Maximum
Length
Number of
Lumens
IN-8823 3mm 400mm 2
IN-6105 3mm 200mm 1
IN-2681 1mm 64mm 1
Summit Cassette Model
Minimum
Inside
Diameter
Maximum
Length
Number of
Lumens
IN-2681 1mm 65mm 1
IN-2681 3mm 200mm 1
IN-8987-S 1mm 500mm 5
IN-8615 2.3mm 210mm 5
IN-6105 4mm 235mm 1
4 Stainless steel lumens with
3mm inner diameter x 400mm
length All appropriate sized
models listed in
Appendix A with the
exception of IN-2681.
2 Stainless steel lumens with
3mm inner diameter x 200mm
length
1 Stainless steel lumen with
3mm inner diameter x 200mm
length IN-2681
1 Stainless steel lumen with
1mm inner diameter x 65mm
length

4
WARNINGS
For aluminum InstruSafe Systems, use only neutral (6.0 – 8.5) pH detergents to avoid damaging the finish. A detergent with a highly
acidic or highly alkaline pH could permanently damage the anodized aluminum finish of the cassette and metal components.
UNIVERSAL PRECAUTIONS
• Personnel should wear all personal protective clothing and equipment as required by their employers/department’s operating
procedures for the contamination level they will be exposed to.
• Keep dissimilar metals separated during sterilization to prevent corrosion.
POINT OF USE
Remove soil with disposable cloth/paper wipe.
CLEANING
Use one of the following validated cleaning options to clean the cassette/tray. Refer to instrument manufacture’s instruction for use for
cleaning the instrument. Use only neutral (6.0 – 8.5) pH solutions, mildly alkaline and free of sodium carbonate to avoid damaging finish
for aluminum cassettes. DO NOT use scouring pads or abrasive cleaners. DO NOT store cassette in liquid.
1. Manual Gross Decontamination:
A. Materials needed: Neutral ph (6.0-8.5) enzymatic detergent, soft bristle brush, running water.
B. Remove all visible soil and contaminates using a soft bristle brush. The entire cassette should be immersed while cleaning to aid in
the removal of contaminates and to reduce splashing of detergent on personnel for a minimum of 2 minutes.
C. Rinse thoroughly for a minimum of 1 minute with clean water to remove all detergent. See rinsing instruction on the detergent
label.
2. Ultrasonic Clean:
Prepare enzyme wash in an ultrasonic cleaning unit. Place a single, cassette in the detergent and run for a minimum of ten minutes.
Rinse for a minimum of 2 minutes with cold tap water. Visually inspect cassette for contaminates. Repeat the cycle if necessary to
remove visible contamination.
3. Automated Washer:
The InstruSafe Instrument Protection Systems are validated for the automatic wash system cycles listed below in Table 1.
Table 1.
Note: Clean and inspect cassettes according to the
instructions provided prior to placing into service.
Note: After completion of an automatic wash cycle, visually inspect the
InstruSafe System (cassette and accessories) for any remaining
visible soil. All visible soil must be removed by hand cleaning,
brushing, ultrasonic or additional automatic cycles prior to sending
to sterilization.
DISINFECTION
InstruSafe systems are intended to be terminally sterilized.
MAINTENANCE, INSPECTION AND TESTING
InstruSafe systems may be reused until unacceptable deterioration such as corrosion, cracking, rust, peeling, flaking, discoloration, or
mechanical failure occurs.
Signs of mechanical failure include:
• Broken or cracked corners or welds
• Broken or non-working latches
• Missing, torn or cut silicone inserts
• Missing or damaged feet
CYCLE WATER TEMPERATURE CLEANING PROCESS
Pre-Wash 1 & 2 Cold Tap Water Re-Circulation Time:
2 Minutes
Enzyme Wash Hot Tap Water Soaking Time:
4 Minutes
Wash 1 Heated At 65.5°C Re-Circulation Time:
15 Minutes
Rinse 1 & 2 Hot Tap Water Re-Circulation Time:
5 Minutes

5
1. Cassette Base – perforated metal trays with feet, handles
and latches. They are available in various lengths, widths
and heights to accommodate dierent sizes of instruments
and numbers of instruments per set.
2. Cassette Cover – perforated metal lids that fit on cassette
base.
3. Hold-It – molded silicone instrument cushions. They attach
to the cassette base with screws directly into the tray or
use an aluminum base. Hold-Its are specifically designed
to hold certain patterns of instruments. This individualized
design provides maximum protection and also allows
instruments to be sterilized in the optimum position for
sterilant penetration and drainage. Do not overload. Load
only one instrument per Hold-It slot. For Hold-It table visit
www.instrusafe.com/resources.
4. Hold-Down – molded silicone cushions. They attach to the
cassette cover with screws directly into the tray or use an
aluminum base. Used in combination with Hold-Its, they
provide 360 degrees of protection for instruments.
5. Handles – retract to save space. They are used to lift the
cassette from sterile containers without contaminating the
sterile contents.
6. Feet – stand the cassette o of the work surface. There
are dierent designs of feet: R has rounded edges and are
designed for wrapping. TF works with rigid containers and
NF is available for no feet needed. See Figure F.
7. Latches – rotate smoothly and hold the cassette cover on
securely with only a quarter turn. To avoid accidents, the
latches visually indicate whether they are open or closed.
They have no springs or sharp edges to catch gloves.
The latches are oset so that covers cannot be put on
backwards (thereby causing a misalignment of Hold-It and
Hold-Down combinations).
8. Divider – used to separate items. Keeps heavy items away
from cords, optics and other delicate instruments.
9. Locating Post – used to separate items. Keeps heavy or
irregular shaped instruments in proper position.
10. Modules – have pairs of molded silicone cushions in an
aluminum shell. They are used in cassettes to protect and
organize similar delicate instruments in sets (i.e. picks and
hooks) and can be easily pulled out and placed on the Mayo
stand during the procedure. They are available in several
sizes and shapes to hold various instrument patterns.
PARTS OF AN INSTRUSAFE INSTRUMENT PROTECTION TRAY SYSTEM
1
7
6
8
9
3
4
5
2
10

6
ASSEMBLY
1. Place the instruments in the predetermined holders or area defined by the locating posts (see Figure A) so that all instrument
surfaces will be exposed to sterilant. Be sure that only one instrument is in each slot. When possible, disassemble or open all
parts of the instrumentation per the instrument manufacturer’s instructions.
Do not overload holders or exceed weight limits of cassettes. See Appendix A.
Figure A.
2. Ensure that handles are positioned inside the cassette (retracted position). Shown in Figure B.
Figure B.
3. Place the cassette cover on the cassette base ensuring that the latches are properly positioned with the latch slot on the
cassette cover, then close the latches. See Figure C.
Figure C.
Figure D.
Note: Complex instruments (e.g., endoscopes, and instruments with
lumens or channels) should be prepared and sterilized according to
the instrument manufacturer’s instructions.
Unlatch
Note: The latches are oset so that the cassette cover always aligns
properly with the tray base. This ensures that the holders are aligned
when the cover is secured. See Figure D. for proper alignment.
Do not force the cassette cover onto the cassette base as it may
damage instruments and the cassette.
Proper Alignment
Improper Alignment

7
PACKAGING
InstruSafe Systems may be wrapped with a legally marketed wrap or placed in a legally marketed rigid container. Refer to sterilization
methods and configurations tables found in the IFU.
Using with Wrap:
1. Before wrapping the cassette, ensure it has the proper foot style. R may be used with wrap. See Figure F.
Figure F.
2. Wrap the cassette using the AAMI CSR double wrap method and per the wrap manufacturer’s instructions.
3. Sterilize the pack using one of the sterilization cycles listed in the IFU.
Using with Rigid Container:
Refer to sterilization methods and configurations tables found in the IFU.
1. Before placing the cassette in a rigid container ensure it has the proper foot style. TF may be used with a rigid container. See
Figure F.
2. Place the cassette(s) into the rigid container. Follow the container manufacturer’s instructions for sealing the container.
Note: Do not wrap the cassettes before placing into the container for sterilization.
3. Sterilize the container and contents using one of the sterilization cycles listed in the IFU.
Additional Information:
To remove the cassette from a rigid container aseptically, follow container manufacturer instructions.
1. With sterile gloved hands. Place palms outward and reach through the openings in the cassette cover.
2. Grasp the cassette handles and lift to their raised position, see Figure G.
Figure G.
3. Tilt the handles inward, away from the sides of the rigid container, and lift the cassette out of the container being careful to not
touch the top or outside of the container.
4. Place cassette on a sterile surface.
‘R’ or Rounders Corner Gaurds
‘TF’ or Tall Foot (for Rigid Containers)

8
STERILIZATION
See Table 2 for sterilization methods and cycles that have been validated for the sterilization of InstruSafe Systems. These are only valid with
sterilization equipment that is properly maintained and calibrated – AAMI TIR 12 p.37. Minimum dry times are required to prevent wet packs.
Table 2.
Summit Medical has validated the following sterilization methods:
• The 4 minute autoclave sterilization cycle in legally marketed wrap, Aesculap rigid container or Genesis rigid container cleared by the FDA.
• The Ethylene Oxide (EO) sterilization cycle in legally marketed wrap and a Genesis sterile container cleared by the FDA.
• The STERRAD 100S Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD 100NX Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD 100NX Express sterilization cycle in legally marketed wrap cleared by the FDA.
• The STERRAD 100NX Flex sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERRAD NX Standard sterilization cycle in legally marketed wrap and an Aesculap rigid container cleared by the FDA.
• The STERIS AMSCO V-PRO, V-PRO 1 PLUS and V-PRO maX sterilization cycles in legally marketed wrap and an Aesculap rigid container
clearedy by the FDA.
Do not exceed the load capacity of the sterile container as specified by the manufacturer.
Use an FDA cleared accessory to maintain sterility.
Please consult the sterilizer instruction manual to ensure intended loads are compatible with the intended sterilization cycle.
Please consult the container instructions to ensure that the intended load is compatible with the FDA cleared loads for the container.
STORAGE
Store terminally sterile cassettes that are wrapped or containerized on storage shelf in a horizontal position. Consult wrap or container
manufacturer for shelf life information.
STERILIZATION METHOD CYCLE (times)
Steam - PreVacuum Parameter:
Temperature 270°F (132°C)
Expose Time 4 minutes
Dry Time 30 minutes
Ethylene Oxide (EO) Preconditioning:
Temperature 131°F (55°C)
Relative humidity 70 ± 15%
Precondition time 1 hour
Sterilization:
Exposure time 120 minutes
Temperature 131°F (55°C)
Aeration time 12 hours
STERRAD 100S Standard
STERRAD 100NX Standard
STERRAD 100NX Express
STERRAD 100NX Flex
STERRAD NX Standard
STERIS AMSCO V-PRO 1 Standard
STERIS AMSCO V-PRO 1 PLUS Lumen, Non-Lumen
STERIS AMSCO V-PRO maX Lumen, Non-Lumen