EleVision HD 2 platform Cleaning and Sterilization Guide

The EleVision™ HD 2 platform is designed to provide clear, consistent visualization in the OR. This guide explains how to care for, clean, and sterilize the EleVision™ HD 2 platform and get the most out of your procedures.

CONTENTS 3 | TipVision™ Videoscope 5 | Camera Heads 7 | Laparoscopes 9 | Light Cables 11 | Insufflator and Pump Accessories

PRECAUTION This guide is a supplement to the approved user manual supplied with the system. Always refer to the applicable version of the user manual. Before use, read the user manual information carefully and follow the specifications regarding concentration, temperature, usage time, water quantities, and contact time. NOTE The manual cleaning process was validated using: Cidezyme™*/Enzol™* The manual disinfection process was validated using: Cidex™* OPA The automated cleaning process was validated using: neodisher™* MediClean forte 0.5 % Wherever possible, use the above cleaning and disinfecting agents only.

TipVision TipVision Videoscope Videoscope

CONTENTS

™™

TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

CLEANING Manual cleaning (OUS): Stage Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning/disinfectant solution

I

Cleaning

Per manufacturer’s instructions

2–5

Tap water

Enzymatic cleaning solution, e.g. Cidezyme™*/Enzol™*

II

Intermediate rinsing 3x

20–30 / 68–86

3x≥2

Tap water

---

III

Disinfection

Per manufacturer’s instructions

12

---

0.55 % ortho-phthalaldehyde solution, e.g. Cidex™* OPA

IV

Rinsing 3x

20–30 / 68-86

3x≥2

Deionized† water

---

V

Drying

---

---

---

---

Stage Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning solution

I

Cleaning

Per manufacturer’s instructions

2–5

Tap water

Enzymatic cleaning solution, e.g. Cidezyme™*/Enzol™*

II

Rinsing 2x

20–30 / 68–86

2x≥2

Tap water

---

III

Final rinsing

20–30 / 68–86

1x≥2

Critical water

---

IV

Drying

---

---

---

---

Stage Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning/disinfectant solution

I

Prerinsing

< 25 / 77

2

Tap water

---

II

Cleaning

55 / 131

10

---

Alkaline cleaning solution, e.g. 0.5 % neodisher™* MediClean forte, prepared per the manufacturer’s instructions

III

Rinsing I

Per the equipment manufacturer’s standard cycle

1

Tap water

---

IV

Rinsing II

Per the equipment manufacturer’s standard cycle

1

Tap water

---

V‡

Thermal disinfection

> 90 / 194

5

Deionized† water

A0 value > 3000

V

Final rinsing

> 90 / 194

5

Critical water

---

Drying

99 / 210

30

---

---

Manual cleaning (US only):

Automated cleaning:

§

VI

† Deionized water (demineralized, low-germ, max. 10 germs/ml, as well as low endotoxin contaminated, max. 0.25 endotoxin units/ml). ‡ OUS only. § US only.

3 | TIPVISION™ VIDEOSCOPE

TipVision Videoscope ™

STERILIZATION To sterilize the TipVision™ videoscope: WARNING Steam sterilization should be performed only for products labeled as autoclavable. Use fully desalinated drinking water that meets the requirements of European Standard EN 285. 1. Make sure that manual or automated cleaning and disinfection is complete. 2. Place the videoscope in the reprocessing tray (ELEVTVTRAY) as per thesubsequent loading plan. First, place the videoscope in the intendedholder first, then wind the cable around the cable guides. The cable shouldn’t be tightened too much. Then place the plug in the dedicated holder and seal the reprocessing tray. 3. Pack the tray with two single layers of sterile wrap - use legally marketed products only. 4. Load the sterilizer as per the validated loading plan. Follow the manufacturer’s instructions and instructions for use for the device. 5. Start the sterilization cycle in accordance with the manufacturer’s instructions, and instructions for use for the sterilizer and the parameters appropriate to the institutional, local and national requirements. NOTE Reprocessing results are achieved using the steam sterilization process with the following validated parameters: Cycle type pre-vacuum process Temperature 134 C (273 F) Holding time at least 3 min (effective sterilization time) Drying time at least 30 min

∙ ∙ ∙ ∙

6. Remove the sterilized products from the sterilizer. Ensure that the products remain sterile after reprocessing. This concludes sterilization.

4 | TIPVISION™ VIDEOSCOPE

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

Camera Heads

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

CLEANING To manually clean the 1CMOS product code: 95-3901 (US only) (product code: 95-3906): Stage Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning/disinfectant solution

I

Cleaning

Per manufacturer’s instructions

2–5

Tap water

Enzymatic cleaning agent: Cidezyme™*/Enzol™*, prepared per manufacturer’s instructions

II

Intermediate rinsing 2x

< 45 / 113

2x≥1

Tap water

III

Final rinsing

< 45 / 113

≥1

Deionized water

IV

Drying

---

---

---

--†

-----

To manually clean the 1CMOS and 3CMOS cameras (OUS only): Stage

Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning solution

I

Cleaning

Per manufacturer’s instructions

2-5

Tap water

Enzymatic cleaning agent, e.g. Cidezyme™*/Enzol™*

II

Intermediate rinse 2x

< 45 / 113

2x≥1

Tap water

---

III

Disinfection

Per manufacturer’s instructions

12

---

0.55% ortho-phthalaldehyde solution, e.g. Cidex™* OPA

IV

Intermediate rinse 2x

< 45 / 113

2x≥1

Tap water

---

V

Final rinse

< 45 / 113

≥1

DI water

---

VI

Dry

---

---

---

---

Automated cleaning and thermal disenfection‡: Stage Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning solution

I

Prerinsing

Cold

2

Tap water

---

II

Cleaning

55 / 131

10

---

Alkaline cleaner: neodisher™* MediClean forte, prepared per manufacturer’s instructions

III

Intermediate rinsing 1

Per the equipment manufacturer’s standard cycle

1

Tap water

---

IV

Intermediate rinsing 2

Per the equipment manufacturer’s standard cycle

1

Tap water

---

V

Thermal disinfection

90 / 194

5

Deionized water† (A0 value: > 3000)

---

VI

Drying

High (98,8 / 210)

30

---

---

† Deionized water (demineralized, low-germ, max. 10 germs/ml, as well as low endotoxin contaminated, max. 0.25 endotoxin units/ml). ‡ Color anodized parts or plastic components may bleach out during automated cleaning.

5 | CAMERA HEADS

Camera Heads

STERILIZATION To sterilize the 1CMOS and 3CMOS cameras: NOTE (1CMOS) STERRAD™*† sterilization was validated for the following cycle: STERRAD™*† 100S short cycle. NOTE (3CMOS) STERRAD™* sterilization was validated for the following cycles: STERRAD™*† 100S Short Cycle (top shelf only) STERRAD™*† NX Standard Cycle (bottom shelf only) STERRAD™*† 100NX Standard Cycle (top shelf only)

∙ ∙ ∙

1. Make sure that manual or automated cleaning is complete. 2. Place the product in a sterilization tray. Place a STERRAD™*† indicator strip in the tray. Double-wrap the tray in polypropylene wrap. 3. Load the wrapped tray in the sterilizer. Position the tray so that the sterilization medium can act thoroughly on all areas. Do not allow any item to touch the wall of the sterilizer. 4. Start the sterilization cycle in accordance with the manufacturer’s instructions and instruction for use for the sterilizer. 5. Remove the sterilized products from the sterilizer. Ensure that the products remain sterile after reprocessing.

† US only.

6 | CAMERA HEADS

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

Laparoscopes

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

CLEANING To manually clean the laparoscopes (US)†: Stage

Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning solution

I

Cleaning

Per manufacturer’s instructions

2-5

Tap water

Enzymatic cleaning solution

II

Rinse 2x

< 45 / 113

2x≥1

Tap water

---

IV

Final rinse

< 45 / 113

≥1

High purity water

---

V

Dry

---

---

---

---

To manually clean the laparoscopes (OUS)†: Stage

Action

Temperature (°C/°F)

Time (min)

Water quality

Cleaning solution

I

Cleaning

35-45 / 95-113

5

Tap water

Enzymatic cleaning solution

II

Intermediate rinse

Room temperature

3x1

Tap water

---

III

Disinfection

20-25 / 66-77

12

---

Disinfectant solution (undiluted)

IV

Final rinse

Room temperature (cold)

3x2

DI water

---

V

Dry

Room temperature

---

---

---

VI

Dry

---

---

---

---

Automated cleaning and thermal disinfection‡: Stage Action

Temperature (°C/°F)

Time (min)

Cleaning solution / Water quality

I

Prerinse

Cold

2

Tap water

II

Cleaning

60 / 140

10

Alkaline detergent

III

Intermediate

per the equipment manufacturer’s standard cycle

1

Tap water

IV

Intermediate rinse

per the equipment manufacturer’s standard cycle

1

Tap water

V

Final rinse

90 / 194

5

Purified water

VI

Dry

98.8 / 210

30

---

†Outside of the United States, material compatibility releases also exist for Gigasept FF (Schülke & Mayr GmbH) for manual cleaning and disinfection, Lysetol FF (Schülke & Mayr GmbH) for manual cleaning and disinfection, and Helipur HplusN (B. Braun Medical AG) for manual disinfection. ‡ Automated reprocessing can cause color-anodized or plastic components (e.g. standard rings and the eyepiece cup) to fade.

7 | LAPAROSCOPES

Laparoscopes

STERILIZATION To sterilize the laparoscopes NOTE Reprocessing results are achieved using the fractionated vacuum steam sterilization process at 134 C and with a holding time of 5 minutes. CAUTION Risk of scalding when unloading the sterilizer. 1. Make sure that manual or automated cleaning and disinfection is complete. 2. Load the sterilizer as per the validated loading plan. Follow the manufacturer’s instructions and instructions for use for the washer/disinfector. 3. Start the sterilization cycle in accordance with the manufacturer’s instructions and instruction for use for the sterilizer. 4. Remove the sterilized products from the sterilizer. Ensure that the products remain sterile after reprocessing. To sterilize using the STERRAD™*† Sterilization Procedure (100S, NX, 100NX) The STERRAD™*† sterilization systems, manufactured by Advanced Sterilization Products (ASP), use low-temperature, hydrogen peroxide gas plasma technology for terminal sterilization of properly cleaned, rinsed, and dried reusable medical devices. 1. Double wrap the endoscope with two single layers of FDA-cleared sterilization wrap using a sequential double wrapping technique. 2. Load the wrapped endoscopes in the sterilizer. Devices should be positioned to permit adequate plasma circulation and penetration. Do not allow any item to touch the wall of the sterilizer. Do not stack wrapped devices in the sterilization chamber. 3. Start the sterilization cycle in accordance with the manufacturer’s instructions and instructions for use for the steam sterilizer. 4. Remove the sterilized products from the sterilizer. Ensure that the products remain sterile after reprocessing.

†The STERRAD™* Sterilization Systems, manufactured by Advanced Sterilization Products (ASP), use low temperature, hydrogen peroxide gas plasma technology for terminal sterilization of properly cleaned, rinsed, and dried reusable medical devices. Refer to the STERRAD™* Sterilization Systems User Guide for detailed instructions for use of any STERRAD™* unit, ASP’s STERRAD™* Sterility Guide (SSG) at www.sterradsterilityguide.com or contact ASP customer service.

8 | LAPAROSCOPES

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

Light Cables

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

CLEANING Manual cleaning and disinfection: Stage

Action

Temperature (°C/°F)

Time (min)

Conc. (%)

Water quality

Cleaning solution

I

Cleaning

35–45 / 95–113

5

0.8

Drinking water

Enzymatic cleaning solution, e.g. Cidezyme™*/Enzol™*

II

Rinsing

Room temperature (cold)

2x1

---

Drinking water

---

III

Disinfection

20–25 / 68–77

12

---

---

Disinfectant solution (undiluted)

IV

Final rinsing

Room temperature (cold)

3x1

---

Deionized water†

---

V

Drying

Room temperature

---

---

---

---

Automated‡ alkaline cleaning and thermal disinfection: Stage

Action

Temperature (°C/°F)

Time (min)

Conc. (%)

Water quality

Cleaning solution / Notes

I

Prerinsing

< 25 / 77

2

---

Drinking water

---

II

Cleaning

55 / 131

10

0.5

Drinking water

Alkaline detergent, e.g. neodisher™* MediClean forte (5 ml / L), pH > 10

III

Rinsing I

> 10 / 50

1

---

Drinking water

---

IV

Rinsing II

> 10 / 50

1

---

Deionized water†

---

V

Thermal disinfection

90 / 194

5

---

Deionized water†

---

VI

Drying

---

---

---

---

---

† Deionized water (demineralized, low-germ, max. 10 germs/ml, as well as low endotoxin contaminated, max. 0.25 endotoxin units/ml). ‡ Automated reprocessing can cause color-anodized or plastic components (e.g. standard rings and the eyepiece cup) to fade.

9 | LIGHT CABLES

Light Cables

STERILIZATION Steam Sterilization 1. Make sure that manual or automated cleaning and disinfection is complete. 2. Load the sterilizer per the validated loading plan and follow the manufacturer’s instructions and instructions for use for the washer/disinfector. 3. Start the sterilization cycle in accordance with the manufacturer’s instructions and instruction for use for the sterilizer. 4. Use the following validated parameters for steam sterilization: Temperature: 134 C (273.2 F) Holding time: 5 minutes (effective sterilization time) 5. Remove the sterilized products from the sterilizer. Ensure that the products remain sterile after reprocessing.

Low-Temperature Plasma-Based Sterilization (LTP) Performing LTP 1. Make sure that manual or automated cleaning and disinfection is complete. 2. Double-package the product using transparent Tyvek™* wrappings. 3. Load the sterilizer and follow the manufacturer’s instructions and instructions for use for the device. 4. Start the sterilization cycle in accordance with the manufacturer’s instructions and instruction for use for the sterilizer. 5. Remove the products from the sterilizer. 6. Continue processing the products as per your validated process - ensure that the products remain sterile after reprocessing.

10 | LIGHT CABLES

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

Insufflator and Pump Accessories

CONTENTS TipVision™ Videoscope Camera Heads Laparoscopes Light Cables Insufflator and Pump Accessories

CLEANING AND STERILIZATION Insufflator Tubesets (Reusable) - OUS Only Cleaning and disinfection: Reusable Insufflation Tubing

Manual cleaning: Neodisher™* Mediclean 2 percent or equivalent Automated cleaning: Vario – Miele or equivalent Disinfection: Lysetol 8 percent or equivalent

Sterilization

Steam Sterilization 132–134 degrees C 5 min

Suction Irrigation Pump Tubesets (Reusable) ­­- OUS Only Reusable Insufflation Tubing

Manual cleaning: Neodisher™* Mediclean 2 percent or equivalent Automated cleaning: Vario – Miele or equivalent Disinfection: Lysetol 8% or equivalent

Sterilization method:

Pre-vacuum sterilizer:

Packaging

Packed

Cycle time

5 minutes (273 F/134 C, 3 bar)

Drying time

10 minutes

11 | INSUFFLATOR AND PUMP ACCESSORIES

Contact your local Medtronic sales representative for more information about the EleVision™ HD 2 platform cleaning and sterilization process.

IMPORTANT: Please refer to the package insert for complete instructions, contraindications, warnings and precautions. © 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 20-weu-elevision-hd2-cleaning-and-sterilization-guide-4582858

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