URF-P7R Operation Manual Dec 2018

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 2 Intended use ... 2 Applicability of endoscopy and endoscopic treatment ... 2 Instruction manual ... 2 User qualifications ... 3 Instrument compatibility ... 3 Reprocessing before the first use/reprocessing and storage after use ... 3 Spare equipment ... 3 Maintenance management ... 4 Prohibition of improper repair and modification ... 4 Signal words ... 4 Warnings and cautions ... 5 Examples of inappropriate handling ... 7

Chapter 1 Checking the Package Contents ... 9 1.1

Checking the package contents ... 9

Chapter 2 Instrument Nomenclature and Specifications ... 11 2.1

Nomenclature and functions ... 11

2.2

Specifications ... 15 Environment ... 15 Specifications ... 16

Chapter 3 Preparation and Inspection ... 19 3.1

The workflow of preparation and inspection ... 19

3.2

Preparation of the equipment ... 21

3.3

Inspection of the endoscope ... 23 Inspection of the endoscope ... 23 Inspection of the bending mechanism ... 27

3.4

Inspection of accessories ... 30 Inspection of the forceps/irrigation plug ... 30

3.5

Attaching accessories to the endoscope ... 31 Attaching the forceps/irrigation plug (MAJ-891) ... 31

3.6

Inspection of ancillary equipment ... 31

3.7

Connection of the endoscope and ancillary equipment ... 32 Connection of the light guide cable ... 32 Connection to the light source ... 34 Connection of irrigation system ... 34

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Contents

3.8

Inspection of the endoscopic system ... 35 Inspection summary ... 35 Inspection of the endoscopic image ... 36 Inspection of the irrigation function ... 37 Inspection of the instrument channel ... 37

Chapter 4 Operation ... 39 4.1

Precautions ... 39

4.2

Insertion ... 42 Holding and manipulating the endoscope ... 42 Irrigation ... 43 Insertion of the endoscope ... 43 Angulation of the distal end ... 46 Observation of the endoscopic image ... 47

4.3

Using EndoTherapy accessories ... 48 Insertion of EndoTherapy accessories into the endoscope ... 49 Operation of EndoTherapy accessories ... 51 Withdrawal of EndoTherapy accessories ... 51

4.4

Using the laser system ... 52 Insertion of the laser probe into the instrument channel ... 52 Operation of the laser system ... 53 Withdrawal of the laser probe ... 53

4.5

Withdrawal of the endoscope ... 53

4.6

Transportation of the endoscope ... 54 Transporting within the hospital ... 54 Transporting outside the hospital ... 54

Chapter 5 Troubleshooting ... 55 5.1

Troubleshooting ... 55

5.2

Troubleshooting guide ... 55 Image quality or brightness ... 56 Irrigation fluid feeding ... 56 Angulation ... 57 EndoTherapy accessories ... 57

5.3

Withdrawal of the endoscope with an irregularity ... 58

5.4

Returning the endoscope for repair ... 59

Appendix ... 61 Combination equipment ... 61 System chart ... 61 Reprocessing equipment ... 63 Compatible EndoTherapy accessories ... 64

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URF-P7/P7R OPERATION MANUAL

Symbols

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

Description Refer to instructions.

Blue

Refer to instructions.

Caution

Endoscope

TYPE BF applied part

Single use only

Lot number

Manufacturer

Authorized representative in the European Community

Serial number

Ingress protection rating is 7.

URF-P7/P7R OPERATION MANUAL

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney through a percutaneous route and transurethrally.

 Applicability of endoscopy and endoscopic treatment If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital’s administrations or other official institutions, such as academic societies on endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

 Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals for all equipment that will be used during the procedure and use the equipment as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “REPROCESSING MANUAL” with your endoscope model listed on the cover. It also accompanied the endoscope at shipment. 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, contact Olympus.

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URF-P7/P7R OPERATION MANUAL

Important Information - Please Read Before Use

 User qualifications If there are official standards for user qualifications to perform endoscopy and endoscopic treatment that are defined by the hospital’s medical administrators or other official institutions, such as academic societies on endoscopy, follow those standards. If there are no official qualification standards, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of urology, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

 Instrument compatibility Refer to “Combination equipment” on page 61 to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient or operator injury and/or equipment damage.

 Reprocessing before the first use/reprocessing and storage after use This instrument was not reprocessed before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope model listed on the cover. After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.

 Spare equipment Be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.

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Important Information - Please Read Before Use

 Maintenance management The probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically following regulations, guidelines, etc. required of you. An endoscope with an observed irregularity should not be used, but should be inspected by following Section 5.2, “Troubleshooting guide”. If the irregularity is still observed after inspection, contact Olympus.

 Prohibition of improper repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner.

 Signal words The following signal words are used throughout this manual:

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, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

4

Indicates additional helpful information.

URF-P7/P7R OPERATION MANUAL

Important Information - Please Read Before Use

 Warnings and cautions Follow the warnings and cautions given below when handling this endoscope. This information is to be supplemented by the warnings and cautions given in each chapter.

WARNING • Do not use this instrument for any purpose other than its intended use. Select the endoscope to be used according to the objective of the intended procedure based on the full understanding of the endoscope’s specifications and functionality as described in this instruction manual. • After using this endoscope, reprocess and store it according to the instructions given in the endoscope’s companion “REPROCESSING MANUAL” with your endoscope model listed on the cover. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection. • Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section, or control section. Also, do not bend, pull, or twist the endoscope’s distal end, insertion tube, bending section, control section, or light guide cable with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. • Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination. • Never insert or withdraw the endoscope’s insertion section while the bending section is locked. When using an endoscope with the UP/DOWN angulation lock, never insert or withdraw the endoscope while the angulation lock is moved in the opposite direction of the “F ” mark. Patient injury, bleeding, and/or perforation may result. • Never operate the bending section, insert or withdraw the endoscope’s insertion section, or use EndoTherapy accessories without viewing the endoscopic image. Patient injury, bleeding, and/or perforation may result. • If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy. Forcible insertion can result in patient injury, bleeding, and/or perforation. • Never insert or withdraw the insertion section abruptly or with excessive force. Patient injury, bleeding, and/or perforation may result. • Do not touch the metal part of the light guide cable immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

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Important Information - Please Read Before Use

WARNING • Do not touch the light guide connector of the endoscope immediately after using the endoscope because it is extremely hot. Disconnect the light guide cable from the endoscope after the temperature decreases. Otherwise, operator or patient burns can result. • Do not touch the light guide connector of the endoscope while using the endoscope because it is extremely hot. Operator or patient burns can result. • Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation, it may also cause alteration of living tissues such as protein denaturation of living tissue and perforation of the tissue by inappropriate using. Observe the following warnings for illumination.  Always set the minimum required brightness.  Always maintain a suitable distance necessary for adequate viewing while using the minimum level of illumination for the minimum amount of time. Do not use close stationary viewing or leave the distal end of the endoscope close to the mucous membrane for a long time without necessity.  When the endoscope will not be used for a long period, be sure to turn OFF the light source or activate the light shield function (standby mode, etc.) so that the endoscope is not illuminated unnecessarily. • If the endoscopic image becomes dimmer during the procedure, it may indicate that blood or mucus is adhering to the examination light outlet on the distal end of the endoscope. Immediately withdraw the endoscope from the patient, remove blood or mucus, and confirm that the examination light outlet has no irregularities to use it again. If you continue to use the endoscope with its obstructed examination light outlet, the temperature at the distal end may rise, which may cause patient injury or operator and/or patient burns. • Never use high-frequency EndoTherapy accessories because the endoscope’s distal end is not insulated. Using high-frequency accessories may pose a risk of an electric shock to the patient and/or endoscope damage may result. • Only use Olympus light guide cables (WA03200A, A03200A, A3290, A3090, A3093) with this endoscope. Other light guide cables could cause the control section of the endoscope to overheat, which could cause operator burns. • If significant resistance is felt during insertion due to an anatomical reason, do not insert or withdraw the endoscope with excessive force. Otherwise, ureter injury, bleeding, and/or perforation may occur.

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URF-P7/P7R OPERATION MANUAL

Important Information - Please Read Before Use

CAUTION • Do not pull the light guide cable. The light guide will be pulled out from the output socket of the light source and the endoscopic image will disappear. • Do not coil the insertion tube with a diameter of less than 10 cm. The insertion tube may be damaged. • Do not attempt to bend or twist the endoscope’s insertion section with excessive force. The insertion section may be damaged. • Do not apply shock to the distal end of the insertion section, in particular the objective lens surface at the distal end. Visual abnormalities may result. • If the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found. In this case, stop using the endoscope, and contact Olympus. • Do not twist or bend the bending section with your hands. Equipment damage may result. • Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leakage.

 Examples of inappropriate handling Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are described below. • Inserting, withdrawing, and using EndoTherapy accessories without a clear endoscopic image may cause patient injury, burns, bleeding, and/or perforation. • Inserting or withdrawing the endoscope or operating the bending section without a clear endoscopic image may cause patient injury, bleeding, and/or perforation.

URF-P7/P7R OPERATION MANUAL

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Important Information - Please Read Before Use

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URF-P7/P7R OPERATION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents Ch.1

Checking the package contents

Match all items in the package with the components shown below. Inspect each item for damage. If the endoscope is damaged, a component is missing, or you have any questions, do not use the items; immediately contact Olympus.

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1.1 Checking the package contents

 Endoscope

Ch.1 URF-P7/P7R

 Accessories

Single use single-ended cleaning brush (BW-400B)

Suction connector cleaning brush (BW-15SH)

Channel-opening cleaning brush (MH-507)

Biopsy valve (MAJ-579, 10 pcs)*1

Forceps/irrigation plug (Isolated type) (MAJ-891)*1

ETO cap (MB-156)

Instruction manual (Forceps/ irrigation plug (Isolated type) (MAJ-891))*1

Operation manual

Reprocessing manual

*1 MAJ-2092 (Luer-split) and instruction manual (Luer-split) are packaged instead of MAJ-891, MAJ-579, and instruction manual (Forceps/irrigation) for Canada.

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URF-P7/P7R OPERATION MANUAL

2.1 Nomenclature and functions

Chapter 2

Instrument Nomenclature and Specifications

The instrument nomenclature, functions, and specifications are described in this chapter.

2.1

Nomenclature and functions

URF-P7/P7R OPERATION MANUAL

Ch.2

11

2.1 Nomenclature and functions

1 2

For URF-P7R

3 4 5

6

Ch.2

18

8

7

9 10 11 13 12

14

17

16

12

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2.1 Nomenclature and functions

No.

Nomenclature

Description

Endoscope model

1

Eyepiece frame (viewfinder)

The viewfinder mask has an index mark indicating the UP direction of all models the bending section.

2

Diopter adjustment ring

Turn the ring to adjust the focus. For photography, set the ring to the ‘click stop’ position before mounting the camera.

all models

3

Eyepiece section

Observe endoscopic images from here.

all models

4

Light guide adapter

Connects the light guide connector and the light guide cable (A3090, A3093, A3290).

all models

5

Light guide connector

Connects the endoscope to the light source using the light guide cable (WA03200A, A03200A). Transfers light from the light source to the all models distal end of the endoscope.

6

Identification mark for STERRAD® 200/NX material compatibility

This mark indicates that this endoscope has material compatibility with the STERRAD® 200/NX Sterilization System.

7

Control section

Operates the endoscope, such as controlling angulation.

all models

8

Forceps/irrigation plug (isolated type)

Accessories are inserted through the forceps port of the forceps/irrigation plug. Fluid can be fed through the irrigation port.

all models

9

Instrument channel port

Attach the forceps/irrigation plug to this port.

10

Color code (white)

This code and numeral show the compatibility of EndoTherapy accessories. The endoscope can be used with EndoTherapy accessories that have the same color code. For more information on combining the endoscope with particular EndoTherapy accessories, all models refer to “ Compatible EndoTherapy accessories” on page 64 and the instruction manuals for the compatible accessories.

Ch.2

all models

all models

• White: URF-P7, URF-P7R 11

Venting connector

Attach the ETO cap or leakage tester here.

all models

12

Boot

Avoids the junction between the insertion tube and control section from bending.

all models

13

ETO cap (MB-156)

The sterilization cap equalizes the outer and inner pressure of the endoscope. The cap must be attached prior to gas sterilization (ethylene oxide gas, STERRAD® etc.) and aeration and removed prior all models to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc.).

14

Insertion section

This section is inserted into the patient body cavity.

all models

15

Distal end

The objective lens and examination light outlet are on this distal end.

all models

16

Bending section

The bending section moves the distal end of the endoscope when the all models UP/DOWN angulation control lever is operated.

17

Insertion tube

Connects the control section and bending section.

18

UP/DOWN angulation lock

Moving this lever in the “F ” direction frees angulation. Moving the lever in the opposite direction locks the bending section at any desired all models position.

URF-P7/P7R OPERATION MANUAL

all models

13

2.1 Nomenclature and functions

For URF-P7R

19

Ch.2

20

Nomenclature

19

UP/DOWN angulation control lever

20

Identification marking This marking indicates that the bending section of the URF-P7R for opposite bending moves in the direction opposite to the conventional endoscopes, such URF-P7R direction as the URF-P5.

14

Description

Endoscope model

No.

When this lever is turned in the “U” direction (for URF-P7R: “Up”), the bending section moves UP; when the lever is turned in the “D” all models direction (for URF-P7R: “Down”), the bending section moves DOWN.

URF-P7/P7R OPERATION MANUAL

2.2 Specifications

2.2

Specifications

 Environment Operating environment

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Standard storage environment (e.g. within the hospital)

Ambient temperature

5 – 40C (41 – 104F)

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Transportation environment (conditions during transportation and short-term storage)

Ambient temperature

–47 to +70C (–52.6 to +158F)

Relative humidity

10 – 95%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

URF-P7/P7R OPERATION MANUAL

Ch.2

15

2.2 Specifications

 Specifications  Endoscope function Model Optical system

URF-P7 Field of view Direction of view

Ch.2

Depth of field Insertion section

URF-P7R

Distal end outer diameter

90 0Forward viewing) 2 – 50 mm ø 2.7 mm (8.1 Fr) 4.9 Fr (Bullet shape)

Distal end enlarged

3

1 Objective lens 2 Examination light outlet 3 Instrument channel outlet 1 Insertion tube outer diameter

Instrument channel

2

ø 2.65 mm (7.95 Fr)

Insertion section working length

670 mm

Channel inner diameter

ø 1.2 mm (3.6 Fr)

Minimum visible distance*1

1.5 mm

Direction from which EndoTherapy accessories enter and exit the endoscopic image

Bending section

Angulation range

Total length

1050 mm

High-frequency treatment Laser treatment

Not compatible Compatible

*1 Distance from the distal end of the endoscope.

16

UP 275 DOWN 275

URF-P7/P7R OPERATION MANUAL

2.2 Specifications

 Common specifications Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a RoHS Directive

Ch.2

This device complies with the requirements of Directive 2011/65/EU concerning electrical and electronic equipment. Year of manufacture

The last digit of the year of manufacture is the second digit of the serial number. In this example, the year is 2017.

Ex. 2701234 (serial number) Degree of protection against electric shock

TYPE BF applied part

Ingress protection rating

IPX7

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