VNLx-J10-Video Naso-Pharyngo-Laryngoscope Reprocessing Instructions for Use June 2016

Contents 1 General······················································································································· 4 1-1.

Foreword·····································································································································4

1-2.

Signal words································································································································6

1-3.

Precautions·································································································································7

1-4.

Applicable reprocessing agents/systems·················································································· 11

1-5.

Procedure flowchart·················································································································· 13

1-6.

Endoscope nomenclature········································································································· 16

1-7.

Function, inspection, and handling of reprocessing accessories·············································· 19

2 Manual reprocessing of VNL8-J10 and VNL11-J10················································ 26 2-1.

Bedside pre-cleaning·················································································································26

2-2.

Leak testing·······························································································································29

2-3.

Manual cleaning························································································································30

2-4.

Manual high level disinfection···································································································35

2-5.

STERRAD® NX®/100NX® sterilization·························································································39

3 Manual reprocessing of VNL15-J10······································································· 43 3-1.

Bedside pre-cleaning·················································································································43

3-2.

Leak testing·······························································································································47

3-3.

Manual cleaning························································································································49

3-4.

Manual high level disinfection···································································································61

3-5.

STERRAD® NX®/100NX® sterilization·························································································68

4 Manual reprocessing of the accessories······························································· 72 4-1.

Manual cleaning························································································································72

4-2.

Manual high level disinfection··································································································· 76

4-3.

STERRAD® NX®/100NX® sterilization·························································································79

4-4.

Steam sterilization·····················································································································79

5 Mechanical reprocessing of endoscope································································ 81 6 Storage of the endoscope and accessories··························································· 82 6-1.

Storage of the disinfected endoscope and accessories····························································82

6-2.

Storage of the sterilized endoscope and accessories·······························································83

7 Disposal···················································································································· 84 8 APPENDIX················································································································ 85 8-1.

PENTAX Medical Compatible Reprocessing Agents/Systems··················································85 3

1

1 General

1-1.

General

Foreword

• This Instructions for Use (IFU) provides adequate instructions for cleaning, high level disinfection, and sterilization validated by PENTAX Medical to ensure the safe and effective reprocessing of the endoscopes and accessories shown Figure 1.1. Refer to the respective IFU for the accessories that are not listed in Figure 1.1. • Review and thoroughly understand this IFU. Failure to read and thoroughly understand the instructions in this IFU may result in serious injury, including infection by cross contamination to the patient and/or user. Furthermore, failure to follow the instructions in the Operation IFU may result in damage to the equipment, or injury (e.g., burns, electric shock, perforation, infection and bleeding). • It is the responsibility of each medical facility to ensure that only well-educated and appropriately trained personnel, who are competent and knowledgeable about endoscopic equipment, antimicrobial agents/processes, and hospital infection control protocol, be involved in the use and reprocessing of these medical devices. • Keep this and all related IFUs in a safe and accessible location for future reference. • If you have any questions or concerns about any information in this IFU, please contact PENTAX Medical.

4

„„ Endoscope

General

1

VNL8-J10/VNL11-J10

VNL15-J10

„„ Accessories for clinical use

Inlet Seal (OF-B190) „„ Accessories for reprocessing

PVE Soaking Cap (OE-C9)

Ventilation Cap (OF-C5)

PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS4010A) *3

PENTAX Medical Cleaning Adapter (OF-B212) *1

PENTAX Medical Cleaning Cap for Instrument Channel Inlet (OF-B218) *2

PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS-C11A) *4

Figure 1.1 *1. PENTAX Medical Cleaning Adapter (OF-B212) referred to simply as Cleaning Adapter (OF-B212) in this IFU. *2. PENTAX Medical Cleaning Cap for Instrument Channel Inlet (OF-B218) referred to simply as Cleaning Cap (OF-B212) in this IFU. *3. PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS4010A) referred to simply as Single Use Cleaning Brush (CS4010A) in this IFU. *4. PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS-C11A) referred to simply as Single Use Cleaning Brush (CS-C11A) in this IFU.

5

1

1-2.

Signal words

The following signal words are used throughout this IFU.

General

Warning

: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution

: Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. It may also be used to alert unsafe practices or potential equipment damage.

Notes

6

: Indicates additional helpful information.

1-3.

Precautions

1

Warning General

• The endoscopes identified in this IFU are reusable semi-critical devices. Since they are packaged non-sterile, they must be cleaned and high level disinfected, or cleaned and sterilized, or cleaned and disinfected and additionally can be sterilized (if applicable) before initial use, as well as after each procedure as well as after repair. • When using the endoscope and accessories on patients with the Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD), be sure to use dedicated instruments/ equipment for such patients only, or immediately dispose of them after use in an appropriate manner. The pathogenic agents that cause (v) CJD cannot be destroyed or inactivated by the cleaning, disinfection, and sterilization methods specified in this IFU for this instrument. Please follow the respective guidelines in your country/region for handling of (v) CJD. • Cleaning of the endoscope and accessories with detergent solution should begin within one hour of the completion of a procedure. If cleaning endoscope and accessories was not begun within one hour after the conclusion of the procedure, dried blood, mucus or other patient debris may cause damage to the devices or interfere with the ability of the user to properly reprocess them. • The use of detergent immediately after each procedure to dissolve and remove organic contaminants and proteinaceous debris is essential to the proper care and maintenance of the endoscope. • Prior to disinfection or sterilization, the endoscopes and accessories must be meticulously cleaned. Failure to do so can result in incomplete or ineffective disinfection or sterilization. • Always inspect reprocessed endoscopes and accessories prior to use according to the separate IFU (Operation). • During the reprocessing process, always wear protective equipment (e.g., gloves, goggle, face mask, gown, etc.) to minimize the risk of cross-infection and chemical injuries. • The air exchange equipment (e.g., ventilation system and exhaust hoods) must be placed in the reprocessing room to minimize the exposure of all persons to potentially toxic vapors. • Endoscopes are semi-critical devices that require cleaning and at least high-level disinfection. Use only legally marketed solutions and/or washer disinfector (WDs) for which validation testing with PENTAX Medical products has been performed by their manufacturers. A list of legally marketed solutions/systems that have been determined to be compatible with PENTAX Medical products is contained in this IFU. • Do not drop the endoscope or subject it to severe impact. Doing so may result in damage to the endoscope.

7

1

Caution

General

• Contact the manufacturer and follow local regulations regarding safe use, appropriate handling, and disposal of cleaning and disinfecting solutions, including alcohol and rinse water. Material Safety Data Sheets available from the cleaning and/or disinfection solution manufacturer should be consulted to provide guidance to end users about the chemical formulation, hazards, chemical and physical properties, first aid, handling and storage, stability, precautions, disposal, etc. • Do NOT twist, rotate or bend excessively any of the strain relief boots (Figure 1.2 (A) and (B)). Doing so may result in instrument damage. Especially, handle the strain relief boot of the insertion portion (Figure 1.2 (A)) with care because it has a smaller diameter. • When carrying the endoscope, do NOT grasp or carry it only by its umbilical cord or insertion portion. Also, do not squeeze or forcibly bend the bending section (Figure 1.3). Doing so may damage the instrument.

Do NOT Twist or Rotate

Do Not Forcibly Bend

(B) (B) (B) (A)

Figure 1.2

8

General

1 Bending Section

Figure 1.3

Caution • After every 100 cycles of STERRAD® NX®/100NX® exposure, the endoscope should be returned to an authorized PENTAX Medical service facility for service. Replacement of the insertion tube and bending section sheath will be necessary, and other components may also require service. • Although STERRAD® NX®/100NX® compatible endoscopes are generally capable of withstanding up to 100 cycles of exposure to STERRAD® NX®/100NX®, repair/ replacement of components might be necessary prior to 100 cycles, depending upon the condition of the endoscope. • Be sure to attach the ventilation cap (OF-C5) to the venting connector before performing STERRAD® NX®/100NX® sterilization.

9

1

Notes • PENTAX Medical flexible endoscopes should not be exposed to temperatures in excess of 60oC (140oF) during either reprocessing or storage. A list of reprocessing agents/systems that

General

are compatible with PENTAX Medical endoscopes is contained in this IFU. Use of incompatible detergent and/or disinfectant may damage the equipment, which may result in unforeseen events that may affect the patient and/or user. • All of the steps in the validated reprocessing protocol described in this IFU are intended to be performed in rapid succession and as a single, continual procedure. There should be no breaks in between steps of the protocol that are of sufficient duration to permit the endoscope to dry to such an extent that dislodged debris and/or microbial contaminants would be permitted to dry onto any endoscope surface. In the event that drying of the endoscope occurs due to an excessive break in the reprocessing procedure, the procedure should be completely repeated, beginning with the first bedside pre-cleaning step. • This IFU contains detailed recommendations on the manual reprocessing of PENTAX Medical endoscopes using PENTAX Medical cleaning/disinfecting adapters. WDs may also be used to reprocess flexible endoscopes. However, only those WDs whose manufacturers provide device-specific instructions and have validation data to support each WD claim with respect to PENTAX Medical instruments should be used. WD manufacturers should be consulted for their specific claims including, but not limited to: A) the ability of the WD to provide a cleaned and high-level disinfected (or sterilized) endoscope and endoscope components (e.g., valves), B) the identification of any special feature (internal channel) or endoscope component that cannot be reprocessed and therefore requires manual reprocessing, C) the microbial quality of the rinse water, D) the inclusion of an “automated” alcohol rinse cycle (optional), E) the inclusion of a terminal drying cycle that removes the majority of water from endoscope channels, F) maintenance procedures for water filter replacement and/or decontamination of the filtration system to ensure water of suitable quality, G) compliance with local regulations and/or guidelines.

10

Applicable reprocessing agents/systems

„„Detergent solution The cleaning process of the endoscopes and accessories described in this IFU has been validated using Endozime® AW or Endozime® (Ruhof Corporation), which is classified as medical grade, low-foaming, neutral pH enzymatic detergent. Endozime® AW and Endozime® are used as the following conditions: Concentration: Add 30 mL of the undiluted solution to 3.8 L (1 U.S. gallon) of clean potable water Temperature: 20 - 30oC (68 - 86oF) (validation test condition) Soaking time: 2 - 3 minutes When using detergent solution other than Endozime® AW or Endozime®, please refer to Chapter 8, Appendix, for specific brand name products that have been tested for material compatibility with PENTAX Medical endoscopes. Reference to specific brand name products in the Appendix is not an endorsement of their efficacy. „„Disinfecting solution The disinfection process of the endoscopes and accessories described in this IFU has been validated using CIDEX® Activated Glutaraldehyde Solution (Advanced Sterilization Products), which is high level disinfectant containing 2.4% glutaraldehyde. CIDEX® Activated Glutaraldehyde Solution is used as the following conditions: Temperature: 25°C (77oF) Soaking time: 45 minutes When using a high-level disinfectant other than CIDEX® Activated Glutaraldehyde Solution, please refer to Chapter 8, Appendix, for specific brand name products that have been tested for material compatibility with PENTAX Medical endoscopes. Reference to specific brand name products in the Appendix is not an endorsement of their efficacy. „„Rinse water Cleaning Use potable water or the water that meets the requirements of the health care facility or local/national infection control requirements. High level disinfection The final rinse should be performed with sterile water. However, if sterile water is not available, use potable water or the water that meets the requirements of the health care facility or local/national infection control requirements. „„Alcohol (if applicable, according to local/national regulation) Use 70 - 90% medical grade ethyl or isopropyl alcohol.

11

1 General

1-4.

„„Sterilization Table 1-1 shows the validated sterilization methods for the endoscopes and accessories described in this IFU.

1

Table 1-1 STERRAD® NX®/

Steam

100NX® system*

sterilization**

VNL8-J10

Y

N

VNL11-J10

Y

N

VNL15-J10

Y

N

Inlet Seal

OF-B190

Y

Y

Cleaning Adapter

OF-B212

N

Y

Cleaning Cap

OF-B218

N

Y

Ventilation Cap

OF-C5

Y***

N

PVE Soaking Cap

OE-C9

N

N

Single Use Cleaning Brush

CS4010A

N

N

Single Use Cleaning Brush

CS-C11A

N

N

Category

General

Endoscope

Product name

Naso-Pharyngo-Laryngoscope

Accessory for clinical use

Accessory for reprocessing

Model name

Y

:: YES

N

:: NO

*

:: Select “Advanced” cycle for the STERRAD® NX® system cycle or “Duo” cycle for the STERRAD® 100NX® system cycle.

**

:: 134 - 137oC (273 - 279oF) x 3 - 18 minutes for the steam sterilization cycles using the pre-vacuum type sterilizer.

***

:: Ventilation cap (OF-C5) must be attached to the endoscope during STERRAD® NX®/100NX® sterilization.

„„Mechanical reprocessing According to ISO 17664, mechanical reprocessing of the endoscopes VNL-J10 Series has been validated successfully while employing the endoscope washer disinfector Wassenburg WD440 / WD440PT by using the combination of cleaner and disinfectant specified below. Please refer to the user manual of the washer disinfector(s) regarding for operation procedures including the connection specifications method also. Detergent & Disinfectant: WASSENBURG® Cleaner & WASSENBURG® PAA EndoHigh® Detergent & EndoHigh® PAA EndoHigh® Detergent & EndoHigh® GTA

12

1-5.

Procedure flowchart

1

„„VNL8-J10 and VNL11-J10

General

Bedside pre-cleaning • Preparation • Wiping the insertion section • Transport to cleaning room

Leak testing

Manual cleaning • Preparation • Cleaning all external surfaces • Soaking in detergent solution • Rinsing • Drying • Visual inspection

Manual High level disinfection • Preparation • Soaking in disinfecting solution • Rinsing • Drying Optional* STERRAD® NX®/100NX® sterilization • Preparation • Wrapping • Loading the sterilizer and operating STERRAD® NX®/100NX® system

*In some countries or circumstances, sterilization is recommended as additional step after cleaning and disinfection.

13

„„VNL15-J10

1

Bedside pre-cleaning • Preparation • Wiping the insertion section • Aspirating detergent solution through the suction channel

General

• Transport to cleaning room

Leak testing

Manual cleaning • Preparation • Cleaning all external surfaces • Brushing the suction channel • Filling the suction channel with detergent solution • Soaking in detergent solution • Rinsing • Drying • Visual inspection

Manual High level disinfection • Preparation • Filling the suction channel with disinfecting solution • Soaking in disinfecting solution • Rinsing • Drying

Optional* STERRAD® NX®/100NX® sterilization • Preparation • Wrapping • Loading the sterilizer and operating STERRAD® NX®/100NX® system

*In some countries or circumstances, sterilization is recommended as additional step after cleaning and disinfection.

14

„„Accessories for clinical use

Ultrasonic cleaning

Optional* STERRAD® NX®/100NX® sterilization or Steam sterilization

or

*In some countries or circumstances, sterilization is recommended as additional step after cleaning and disinfection.

„„Accessories for reprocessing

Cleaning Adapter (OF-B212)

Manual high level disinfection Manual cleaning

Ultrasonic cleaning

Optional*

Steam sterilization

or

Cleaning Cap (OF-B218)

PVE Soaking Cap (OE-C9)

Ventilation Cap (OF-C5)

Manual cleaning

Manual high level OE-C9 should be attached disinfection to the endoscope during cleaning and disinfection procedures.

STERRAD® NX®/100NX® sterilization OF-C5 should be attached to the endoscope during STERRAD 100NX sterilization. ®

TM

Single Use Cleaning Brush (CS4010A) Disposable Single Use Cleaning Brush (CS-C11A)

Single Use Suction Control Valve (OF-B205)

15

1 General

Inlet Seal (OF-B190)

Manual cleaning

Manual high level disinfection

1

1-6.

Endoscope nomenclature

„„Control body, Insertion portion PENTAX Medical Single Use Suction Control Valve (OF- B205)*1

General Remote Buttons

Remote Buttons

Strain Relief Boot D U

D U

Inlet Seal (OF- B190)

Strain Relief Boot

Angulation Control Lever

Control Body

Instrument Channel Inlet

Distal End Bending Section

Bending Section Sheath Model Name Label Insertion Portion

Strain Relief Boot

Insertion Tube STERRAD® NX®/100NX® system compatibility identification symbol

VNL8-J10/VNL11-J10

STERRAD® NX®/100NX® system compatibility identification symbol

Model Name

Minimum Instrument Channel Width

VNL15-J10 Model Name

Remote Buttons

Suction Cylinder

Figure 1.4 *1. PENTAX Medical Single Use Suction Control Valve (OF-B205) referred to simply as Single Use Suction Control Valve (OF-B205) in this IFU. 16

„„PVE connector

1

PVE Connector Serial Number Date of Manufacture

General

Electrical Contacts

Manufacturer Label Umbilical Cord

Strain Relief Boot

Venting Connector

Light Guide Plug

Figure 1.5

17

„„Internal channel system of VNL15-J10

1

Suction Cylinder

Instrument Channel Inlet

Distal End

General Suction Channel

Figure 1.6

18

1-7.

Function, inspection, and handling of reprocessing accessories

1-7-1.

1

PVE Soaking Cap (OE-C9)

General

Caution • NEVER use the PVE soaking cap (OE-C9) when abnormality is suspected in inspection. Replace it with the new one. Using the PVE soaking cap (OE-C9) with abnormality may cause ingress of liquid inside the endoscope, and may result in damage to the instrument. (1) Arrow (2) Sealing surfaces (1)

(2)

Figure 1.7 „„Function OE-C9 is attached to the electrical contacts of PVE connector in order to maintain waterproofing when the endoscope is immersed in reprocessing fluids such as cleaning solution, disinfecting solution, and rinse water. „„Inspection 1. Check that there is no cracking on the outer surface of OE-C9. 2. Check that there are no scratches, cracking, or chipping of the sealing surfaces inside OE-C9. „„Handling 1.

Align the alignment pin on the venting connector with the groove of OE-C9. (1) Alignment pin (2) Arrow (1) (2)

Figure 1.8

19

2. Attach OE-C9 to the electrical contacts by pushing in and rotating OE-C9 clockwise until it stops.

1 General

Figure 1.9

1-7-2.

Ventilation Cap (OF-C5) Caution

• NEVER use the ventilation cap (OF-C5) when abnormality is suspected in inspection. Replace it with the new one. Using the ventilation cap (OF-C5) with abnormality may result in difficulty of attaching/removing it to/from the endoscope. (1) O-ring (2) Locking groove

(1)

(2)

Figure 1.10 „„Function OF-C5 is attached to the venting connector of PVE connector in order to prevent damage to the endoscope during STERRAD® NX®/100NX® sterilization and transportation by air freight. „„Inspection 1. Make sure that of the locking groove potion of OF-C5 is not deformed. 2. Check that there are no scratches, cracking, or chipping of the O-ring inside OF-C5.

20

„„Handling 1.

1

Align the alignment pin on the venting connector with the groove of OF-C5. (1) Locking groove (2) Alignment pin

(2)

General

(1)

Figure 1.11 2. Attach OF-C5 to the venting connector by pushing in and rotating OF-C5 clockwise until it stops.

Figure 1.12

21