EndoTherapy COAGULATION ELECTRODE Instructions

Contents

Contents Symbols...

1

Important Information - Please Read Before Use 2 Intended Use ... Instruction Manual ... User Qualifications... Instrument Compatibility ... Reprocessing and Storage ... Repair and Modification ... Signal Words ... Warnings...

Chapter 1 1.1

Checking the Package Contents...

6

Checking the Package Contents ...

6

Chapter 2 2.1 2.2

Instrument Nomenclature and Specifications ...

7

Nomenclature and Functions... Specifications...

7 9

Chapter 3 3.1 3.2 3.3

14 15 18

Reprocessing... 27

General Policy ... Required Reprocessing Equipment ... Cleaning... Sterilization ...

Chapter 5 5.1 5.2

Preparation, Inspection and Operation ... 13

Preparation ... Inspection ... Operation ...

Chapter 4 4.1 4.2 4.3 4.4

2 2 2 3 3 3 4 4

27 30 32 34

Storage ... 37

Inspection Before Storage ... Storage ...

COAGULATION ELECTRODE CD-6C-1

37 38

i

Contents

Chapter 6

ii

EMC information ... 39

COAGULATION ELECTRODE CD-6C-1

Symbols

Symbols The meaning(s) of the symbol(s) shown on the package, the back cover of this instruction manual and/or this instrument are as follows:

Refer to instructions.

Lot number.

Manufacturer Authorized representative in the European Community Keep away from sunlight

Keep dry

Not Made with Natural Rubber Latex 70C -40C

Temperature limitation

TYPE BF applied part

For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf COAGULATION ELECTRODE CD-6C-1

1

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended Use This instrument has been designed to be used with Olympus endoscopes to electrosurgically cauterize or to perform electrosurgical hemostasis within the upper airways, tracheobronchial tree and urinary organs. Do not use this instrument for any purpose other than its intended use.

Instruction Manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

User Qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.

2

COAGULATION ELECTRODE CD-6C-1

Important Information - Please Read Before Use

Instrument Compatibility Refer to the Tables in Section 2.2, “Specifications” to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage.

Reprocessing and Storage This instrument and A Cord were not sterilized before shipment. Before using this instrument and A Cord for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”. After using the instrument and A Cord, reprocess and store them according to the instructions in Chapter 4, “Reprocessing” and Chapter 5, “Storage”. Improper and/or incomplete reprocessing can present an infection control risk, cause equipment damage or reduce performance.

Repair and Modification This instrument and A Cord contain no user-serviceable parts. Do not disassemble, modify or attempt to repair; patient or user injury and equipment damage can result.

COAGULATION ELECTRODE CD-6C-1

3

Important Information - Please Read Before Use

Signal Words The following signal words are used throughout this manual: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. Indicates additional helpful information.

Warnings Follow the warnings described below when handling this instrument and A Cord. This information is supplemented by the warnings described in each chapter. •

4

The instrument, SD Handle or A Cord, when applied to a patient with a pacemaker implanted, may cause malfunctioning or failure of the pacemaker, seriously affecting the patient. Always confirm that it is safe to proceed with a cardiologist or the manufacturer of the pacemaker before proceeding.

COAGULATION ELECTRODE CD-6C-1

Important Information - Please Read Before Use

•

When using the instrument, SD Handle or A Cord in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart.

•

When using an electrocardiograph or other physiological monitoring equipment simultaneously with the instrument, SD Handle or A Cord on a patient, any monitoring electrodes should be placed as far away as possible from the electrodes used with the UES-30. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring equipment incorporating high-frequency current limiting devices is recommended.

•

The electrosurgical unit should not be used adjacent to or stacked with other electrical equipment, except equipment that is intended for this purpose and tested by the manufacturer.

•

Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable memory and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this equipment, or shielding the location.

COAGULATION ELECTRODE CD-6C-1

5

Chapter 1 Checking the Package Contents

Chapter 1 1.1

Checking the Package Contents

Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument or A Cord is damaged, a component is missing or you have any questions, do not use the instrument or A Cord; immediately contact Olympus. The instrument and A Cord were not sterilized before shipment. Before using the instrument and A Cord for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”.

 B set

Coagulation Electrode

Instruction Manual

 A Cord (MH-969) A Cord (1 piece)

6

COAGULATION ELECTRODE CD-6C-1

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2

2.1

Instrument Nomenclature and Specifications

Nomenclature and Functions This instrument must be used in combination with the A Cord.

 Coagulation Electrode 2. Plug 1. Model Reference Label

Lot Number Insertion Portion/ Working Length

3. Distal Tip

5. Tube 4. Marking

COAGULATION ELECTRODE CD-6C-1

7

Chapter 2 Instrument Nomenclature and Specifications

 A Cord (MH-969) 6. A Cord Jack 7. Model Reference Label 8. Cable

9. A Cord Plug

1. Model Reference Label Indicates the product number. A green model reference label indicates that the instrument is autoclavable. 2. Plug Connects to the A Cord Jack. 3. Distal Tip Cauterizes or coagulates tissue by applying high-frequency current. 4. Marking Used as a reference in the endoscope field of view so that the Distal Tip and Scope Tip may be kept at a distance that allows safe activation of the electrosurgical unit. 5. Tube Isolates high-frequency current. 6. A Cord Jack Connects to the Plug on the instrument. A green reference label indicates that the A Cord is autoclavable. 7. Model Reference Label Indicates the product number. 8. Cable Transmits high-frequency current from the connected electrosurgical unit to the instrument.

8

COAGULATION ELECTRODE CD-6C-1

Chapter 2 Instrument Nomenclature and Specifications

9. A Cord Plug Connects to the A Cord Plug connector of the electrosurgical unit.

2.2

Specifications The compatible Olympus endoscopes are listed in the Table on the following page. New endoscopes released after the introduction of this instrument and A Cord may also be compatible for use in combination with this instrument and A Cord. For further details, contact Olympus. Use the instrument and A Cord only in combination with products recommended by Olympus. If combined with products not recommended by Olympus, patient injury caused by increase in patient leakage current, operator injury, malfunction or equipment damage may result. •

Never use the instrument and A Cord with an endoscope that is incompatible with high-frequency current. Using an incompatible endoscope may compromise patient or user safety, such as tissue burning or thermal injury and may result in more severe equipment damage.

•

Do not use the instrument and A Cord with activating output over the rated high-frequency voltage in the Table on the following page. This could cause patient, operator or assistant injury, such as thermal injury. It could also damage the endoscope, instrument and/or A Cord.

COAGULATION ELECTRODE CD-6C-1

9

Chapter 2 Instrument Nomenclature and Specifications

When using the PSD-10, the P Cord (MB-582 or MB-584) is necessary. The S-P Cord is unnecessary.

Environment Operating

Ambient

Environment

Temperature

10 – 40C (50 – 104F)

Relative Humidity

30 – 85%

Atmospheric

700 – 1060 hPa

Pressure

(0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Transportation

Ambient

and Storage

Temperature

Environment

-40 – +70C (-40 – +158F)

Relative Humidity

10 – 95%

Atmospheric

700 – 1060 hPa

Pressure

(0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Specifications Model

CD-6C-1

Shape of the Distal End

Maximum Insertion Portion Diameter (mm) Working Length (mm) Rated High-frequency Voltage

ø 1.9 1050 CUT: 1600 Vp (3200 Vp-p) COAG: 2900 Vp (5800 Vp-p)

10

COAGULATION ELECTRODE CD-6C-1

Chapter 2 Instrument Nomenclature and Specifications

Compatible

Model and

Working Length less than 600 mm

Olympus

Length

BF (High-frequency compatible

Endoscope

endoscopes only*1)

(All of these

ENF (High-frequency compatible

parameters

endoscopes only*1)

should be met.)

CYF (High-frequency compatible endoscopes only*1) Channel Inner Diameter (mm)

ø 2.0, ø 2.2, ø 2.4 (Blue): ø 2.6 (Green): ø 2.8, ø 3.2 (Yellow)

(Color Code) Compatible Olympus

PSD-20, PSD-30, PSD-60,

Electrosurgical Unit

UES-20, UES-30, ESG-100

Compatible Olympus A Cord

MH-969, MAJ-860

Total length of compatible

MH-969: 2

Olympus A Cord (m)

MAJ-860: 2

1 For more detail, refer to the “System chart” in the Appendix and select a compatible EndoTherapy accessory in the instruction manual of each endoscope. Medical

This device complies with the

Devices

requirements of Directive

Directive

93/42/EEC concerning medical devices. Classification: Class II b

Degree of

TYPE BF

When this instrument is used in

Protection

combination with the

against

equipment listed above.

electric shock of Applied Part

COAGULATION ELECTRODE CD-6C-1

11

Chapter 2 Instrument Nomenclature and Specifications

EMC

Applied standards;

This instrument complies with

IEC 60601-1-2:

the standards listed in the left

2001

column.

IEC 60601-2-2: 2006

CISPR 11 of emission:

IEC 60601-1-2:

Group 1, Class B

2007 IEC 60601-2-2: 2009 IEC 60601-1-2: 2014

This instrument complies with the EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001), edition 3 (IEC 60601-1-2: 2007), and edition 4 (IEC 60601-1-2: 2014). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

12

COAGULATION ELECTRODE CD-6C-1

Chapter 3 Preparation, Inspection and Operation

Chapter 3

Preparation, Inspection and Operation •

The instrument, SD Handle or A Cord, when applied to a patient with a pacemaker implanted, may cause malfunctioning or failure of the pacemaker, seriously affecting the patient. Always confirm that it is safe to proceed with a cardiologist or the manufacturer of the pacemaker before proceeding.

•

Before each case, prepare and inspect the instrument and A Cord as instructed below. Inspect other equipment to be used with the instrument and A Cord as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument or A Cord; contact Olympus. Damage or irregularity may compromise patient or user safety, such as perforation, bleeding, mucous membrane damage, tissue burning or thermal injury and may result in more-severe equipment damage.

COAGULATION ELECTRODE CD-6C-1

13

Chapter 3 Preparation, Inspection and Operation

•

The instrument and A Cord were not sterilized before shipment. Before using the instrument or A Cord for the first time, reprocess them according to the instructions in Chapter 4, “Reprocessing”. Do not use an instrument or A Cord that has not been cleaned and sterilized. This poses an infection control risk and can cause tissue irritation.

•

It might be impossible to stop bleeding depending on the hemorrhage situation because the instrument performance for hemostasis is limited. Prepare more than one hemostatic device and select appropriate hemosratic device or use it together to respond to different hemorrhage situations appropriately. Choose a surgical hemostasis if necessary. Do not coil the Insertion Portion with a diameter of less than 15 cm. This could damage the Insertion Portion.

3.1

Preparation Equipment and Personal Protective Equipment Prepare all equipment and personal protective equipment which will be used with the instrument and A Cord in accordance with their respective instruction manuals. Appropriate personal protective equipment may include: Eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves.

14

COAGULATION ELECTRODE CD-6C-1

Chapter 3 Preparation, Inspection and Operation

Spare Instrument and A Cord Always have a spare instrument and A Cord available.

Reprocessing Equipment Prepare reprocessing equipment as described in Section 4.2, “Required Reprocessing Equipment” for immediate reprocessing after use.

3.2

Inspection Wear the personal protective equipment as specified in the Table on page 31. Before each case, always inspect the instrument and A Cord according to the following procedures. If an abnormality in the instrument or A Cord is detected, use a spare instrument or A Cord inspecting it thoroughly before use.

Inspection of the Sterile Package Inspect the sterile package for tears, inadequate sealing or water damage. If the sterile package shows any irregularities, the sterile condition of the instrument or A Cord may have been compromised. Use a spare instead.

Appearance Inspection If any of following steps reveals irregularities, do not use the instrument or A Cord; use a spare instead.

COAGULATION ELECTRODE CD-6C-1

15

Chapter 3 Preparation, Inspection and Operation

 Inspecting the Instrument 1. Confirm that the instrument is free from disconnection or looseness.

2. Gently run your fingertips over the entire length of the Insertion Portion to check for any crushed areas, excessive bends, broken areas or other damages.

3. Confirm that the Distal Tip appears exactly as shown in the Tables in Section 2.2, “Specifications” and is not damaged.

4. Make sure there are no sharp protrusions, edges or other damage at the distal end of the Insertion Portion.

5. Confirm that there is no faintness or peeling of the Marking at the distal end of the Tube.

 Inspecting the A Cord Make sure that there are no scratches or cracks on the A Cord.

Making and Inspecting the Connections •

Do not connect any equipment or inspect any connections when the electrosurgical unit is ON. This could cause operator or assistant injury, such as thermal injury.

•

Do not pull the cable to unplug the A Cord Plug or A Cord Jack. This could damage the A Cord.

If any of following steps reveals irregularities, do not use the instrument or A Cord; use a spare instead.

16

COAGULATION ELECTRODE CD-6C-1

Chapter 3 Preparation, Inspection and Operation

 Connecting the Instrument to the A Cord and Inspecting the Connection 1. Insert the A Cord Jack into the Plug and confirm that it clicks into place (see Figure 3.1).

A Cord Jack

Plug

Figure 3.1

2. Remove the A Cord Jack.  Connecting the A Cord to an Electrosurgical Unit and Inspecting the Connection 1. Insert the A Cord Plug into the electrosurgical unit’s A Cord Plug connector and confirm that it clicks into place.

2. Remove the A Cord Plug.

COAGULATION ELECTRODE CD-6C-1

17