EC38-i10Nx Series Video Colonoscope Reprocessing Instructions for Use Aug 2016

Contents 1 General······················································································································· 2 1-1.

Foreward·····································································································································2

1-2.

Signal words································································································································4

1-3.

Precautions·································································································································5

1-4.

Applicable reprocessing agents/systems····················································································8

1-5.

Procedure flowchart·················································································································· 10

1-6.

Endoscope nomenclature········································································································· 13

1-7.

Function, inspection, and handling of reprocessing accessories·············································· 17

2 Manual reprocessing of the endoscope································································ 25 2-1.

Bedside pre-cleaning·················································································································25

2-2.

Leak Testing·······························································································································32

2-3.

Manual cleaning························································································································33

2-4.

Manual high level disinfection···································································································52

2-5.

Optional sterilization··················································································································63

3 Manual reprocessing of the accessories······························································· 64 3-1.

Manual Cleaning·······················································································································64

3-2.

Manual High Level Disinfection·································································································69

3-3.

Steam Sterilization····················································································································73

4 Mechanical reprocessing of endoscope································································ 75 5 Storage of the endoscope and accessories··························································· 76 5-1.

Storage of the disinfected endoscope and accessories···························································· 76

5-2.

Storage of the sterilized accessories························································································78

6 Disposal···················································································································· 79 7 APPENDIX················································································································ 80 7-1.

PENTAX Medical Compatible Reprocessing Agents/Systems··················································80

1

1

1 General

1-1.

General

Foreward

• This Instructions for Use (IFU) provides adequate instructions for cleaning, and high level disinfection 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 the endoscopic equipment, antimicrobial agents/processes, and hospital infection control protocol, be involved in the use and the reprocessing of these medical devices. • Keep this IFU 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.

2

„„ Endoscope

General

1

EC38-i10NL/EC38-i10NF „„ Accessory for clinical use

Inlet Seal (OF-B190)

Irrigation Tube (OF-B113)

„„ Accessory for reprocessing

PENTAX Medical Soaking Cap for Navigation Connector (OE-C27)

PVE Soaking Cap (OE-C9)

Ventilation Cap (OE-C21)

Cleaning Adapter (OF-B153)

Cleaning Adapter (OF-G17)

Cleaning Brush (CS6021T)

Cleaning Brush (CS-C9S)

Figure 1.1

3

1

1-2.

Signal words

The following signal words are used throughout this IFU.

General

4

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

: Indicates additional helpful information.

1-3.

Precautions

1

Warning General

• The endoscopes identified in this IFU are reusable semicritical devices. Since they are packaged non-sterile, they must be cleaned and high level disinfected 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. • 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. • Please note that the forward water jet channel must undergo all steps of the endoscope reporocessing procedure, regardless of whether it was used during a clinical procedure.

5

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 (as indicated by (A) and(B) in the Figure 1.2). Doing so may result in instrument damage. Especially, handle the strain relief boot of the insertion portion (as indicated by (A) in the Figure 1.2) 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 Forcefully Bend

Do Not Twist or Rotate

(A) (B)

Figure 1.2

6

(B)

General

1 Bending Section

Figure 1.3

Notes • PENTAX 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 are compatible with PENTAX Medical endoscopes is contained in this manual. • 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 supplied cleaning/disinfecting adapters. WD may also be used to reprocess flexible endoscopes. However, only those WD should be used whose manufacturers provide device-specific instructions and have validation data to support each WD claim with respect to PENTAX Medical instruments. WD manufacturers should be consulted for their specific claims including, but not necessarily 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, (if applicable) E) the inclusion of a terminal drying cycle that removes the majority of water from within 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.

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1

1-4.

Applicable reprocessing agents/systems

General

„„Detergent solution The cleaning process of the endoscopes and accessories described in this IFU has been validated using Endozime® or Endozime® AW (Ruhof Corporation), which is classified as medical grade, lowfoaming, neutral pH enzymatic detergent. Endozime® and Endozime® AW 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 (validation test condition) Soaking time: 2 - 3 minutes When using detergent solution other than Endozime® or Endozime® AW, please refer to Chapter 7, 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. „„Disinfectant 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 Soaking time: 45 minutes When using a high-level disinfectant other than CIDEX® Activated Glutaraldehyde Solution, please refer to Chapter 6, 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) Use 70 - 90% medical grade ethyl or isopropyl alcohol.

8

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

Accessory for clinical use

Accessory for reprocessing

Product name

Model name

Steam sterilization*

Inlet Seal

OF-B190

Y

Suction Control Valve

OF-B120

Y

Air/Water feeding Valve

OF-B188

Y

Water Jet check valve adapter

OE-C12

Y

Check Valve

OE-C14

Y

Water Jet Connector Cap

OF-B118

Y

Irrigation tube

OF-B113

Y

PVE Soaking Cap

OF-C9

N

Ventilation Cap

OE-C21

N

Soaking Cap for Navigation Connector

OE-C27

N

Cleaning Adapter

OF-B153

Y

Cleaning Adapter

OF-G17

Y

Cleaning Brush

CS6021T

N

Cleaning Brush

CS-C9S

Y

Y

:: YES

N

:: NO

*

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

General

Category

1

„„Mechanical reprocessing According to ISO 17664, mechanical reprocessing of the endoscopes EC38-i10NL and EC38-i10NF 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. -- Wassenburg Cleaner and Wassenburg PAA”

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1

1-5.

Procedure flowchart

„„Endoscope Bedside pre-cleaning

General

• Preparation • Wiping the insertion section • Aspirating detergent solution through the suction channel • Flushing the air/water channel with air • Flushing the water jet channel with detergent solution • Transporting to cleaning room

Leak testing

Manual cleaning • Preparation • Cleaning all external surfaces • Brushing the suction channel, cylinder, port and component • Filling detergent solution into channels • Soaking in detergent solution • Rinsing • Drying

Manual High level disinfection • Preparation • Filling disinfecting solution into channels • Soaking in disinfecting solution • Rinsing • Drying

10

„„Accessory

1 General

Inlet Seal (OF-B190)

Optional* Manual high level disinfection

Suction control valve (OF-B120)

Manual cleaning

Ultrasonic cleaning

Steam sterilization

Air/Water Feeding Valve (OF-B188)

Water Jet Check-Valve Adapter (OE-C12)

Irrigation Tube (OF-B113)

Cleaning Adapter (OF-B153)

Optional* Manual high level disinfection Manual cleaning

Ultrasonic cleaning

Steam sterilization

Cleaning Adapter (OF-G17)

Cleaning Brush (CS-C9S)

*: In some countries or circumstances, a sterilisation is recommended as additional step after cleaning and disinfection. 11

1 General

PVE Soaking Cap (OE-C9)

PENTAX Medical Soaking Cap for Navigation Connector (OE-C27)

Ventilation Cap (OE-C21)

12

Manual cleaning

OE-C9 og OE-C27 skal sidde på endoskopet under rengørings- og desinfektionsproceduren

Manual high level disinfection

1-6.

Endoscope nomenclature

1 General

„„Control body, Insertion portion

7 3

1

9

10 12

5 2 4

Distal End Bending Section

11 Control Body

13

1

10

Insertion Portion (The parts which come into contacts with the patient)

6 8

Insertion Tube

Figure 1.4

13

1. Remote Buttons 1-4 2. Up/Down Angulation Control Knob 3. Up/Down Angulation Lock Lever 4. Left/Right Angulation Control Knob 5. Left/Right Angulation Lock Knob 6. Suction Cylinder 7. Suction Control Valve (OF-B120) 8. Air/Water Cylinder 9. Air/Water Feeding Valve (OF-B188) 10. Strain Relief Boot 11. Instrument Channel Inlet 12. Inlet Seal (OF-B190) 13. Model Name Label

1 General

Minimum Instrument Channel Width

Model Name

Figure 1.5

14

„„PVE connector

Electrical Contacts

1

16

Manufacturer Label

17

General

PVE Connector (180° rotatable) 10

14 19 Date of Manufacture

Umbilical Cord

Serial Number 18

21

15

20

Figure 1.6 14. Light Guide Plug 15. Suction Nipple 16. Air/Water Port 17. Water Jet Port 18. Water Jet Check-Valve Adapter (OE-C12) 19. Navigation Connector 20. Venting Connector 21. Feedback Terminal

15

„„Internal channel

1

(1)

(3)

(2)

(5)

(4)

(1) Water Nozzle (2) Air Nozzle (3) Water Channel (4) Air Channel (5) Suction Channel (6) Water Jet Channel (7) Instrument Channel (8) Suction Nipple

(7)

(6)

General (8)

Figure 1.7

16

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. • Be careful not to pinch your fingers between the OE-C9 and the Venting connector when detaching OE-C9 from the electrical connector, as it may result in injury.

(1) Arrow (2) Sealing surfaces (1)

(2)

Figure 1.8 „„Function OE-C9 is attached to the electrical contacts of PVE connector, and is used 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 electrical contacts with the arrow of OE-C9. (1) Alignment pin (2) Arrow

(1) (2)

Figure 1.9

17

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

1 General

Figure 1.10

1-7-2.

PENTAX Medical Soaking Cap for Navigation Connector (OE-C27) Caution

• NEVER use the Soaking cap for Navigation Connector (OE-C27) when abnormality is suspected in inspection. Replace it with the new one. Using the Soaking cap for Navigation Connector (OE-C27) with abnormality may result in damage to the instrument. • Always attach OE-C27 to the endoscope when immersing it in water or detergent/disinfecting solution. When the endoscope is immersed without attaching OE-27, water or detergent/ disinfecting solution is likely to remain inside the connector despite its watertight construction. Using the endoscope with water or detergent/disinfecting solution remaining on the electrical contact portion inside the Navigation Connecter may result in damage to the instrument.

Figure 1.11 „„Function The OE-C27 is used to protect the electrical contacts of the navigation connector. „„Inspection 1.

18

Check that there is no cracking on the all external surface of OE-C27.

„„Handling 1.

1

Attached to the navigation connector of PVE Connector.

General

(1) Navigation Connector

(1)

Figure 1.12 2. Check that the soaking cap for navigation connector is attached correctly.

Correct

Wrong

Figure 1.13

1-7-3.

Cleaning Adapter (OF-B153) Caution

• NEVER use the Cleaning Adapter (OF-B153) when abnormality is suspected in inspection.

Rubber Portion

Backside

Figure 1.14 „„Function The OF-B153 can be attached to the air/water cylinders and suction cylinders of endoscopes for cleaning and high-level disinfection of the air/water/suction channels. This adapter caps (seals) off the air/water and suction cylinders to allow unidirectional flow of solution through these delivery/aspiration systems.

19