UCR ENDOSCOPIC CO2 REGULATION UNIT Instructions July 2016

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 5 Intended use ... 5 Applicability of endoscopy, endoscopic treatment, and endoscopic surgery ... 5 Instruction manual ... 5 User qualifications ... 6 Instrument compatibility ... 6 Repair and modification ... 6 Signal words ... 7 Dangers, warnings, and cautions ... 7

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13

1.2

Optional items ... 14

Chapter 2 Instrument Nomenclature ... 17 2.1

Symbols and descriptions ... 17

2.2

Front panel ... 18

2.3

Rear panel ... 20

2.4

Gas tube (MAJ-1741) ... 22

2.5

Optional components ... 23

Chapter 3 Installation and Connection ... 25 3.1

Installation workflow ... 25

3.2

Installation of the endoscopic CO2 regulation unit ... 26

3.3

Connecting a CO2 gas cylinder ... 26

3.4

Connecting the medical gas pipeline adapter (MAJ-1084, MAJ-1085) ... 29

3.5

Connecting to an AC power supply ... 30

3.6

Connecting the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 32

3.7

Connecting the water container and endoscope ... 34

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Chapter 4 Inspection ... 35 4.1

Inspection before use ... 35

4.2

Inspection workflow ... 36

4.3

Inspection of the cylinder hose (MAJ-1080, MAJ-1081, MAJ-1082) ... 37

4.4

Inspection of the medical gas pipeline adapter (MAJ-1084, MAJ-1085) ... 37

4.5

Inspection of the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 38

4.6

Inspection of the endoscopic CO2 regulation unit ... 38 Inspection of the power supply ... 38 Inspection of the gas supply ... 39 Inspection of insufflation ... 40 Inspection of gas feeding at gas tube ... 41 Inspection of gas and water feeding ... 42 Power OFF ... 43

Chapter 5 Operation ... 45 5.1

Precaution for operation ... 45

5.2

Operation flow ... 46

5.3

Function setting before use ... 47 Turn the endoscopic CO2 regulation unit ON ... 47 Selecting the gas supply source ... 47 Timer setting ... 48

5.4

Gas supplying and water feeding ... 49

5.5

After use ... 50 Disconnecting the CO2 gas cylinder ... 50 Disconnecting the medical gas pipeline ... 51

Chapter 6 Care, Storage, and Disposal ... 53 6.1

General policy ... 53

6.2

Precautions ... 54

6.3

Compatible reprocessing methods and chemical agents ... 55 Detergent solution ... 56 Disinfectant Solution ... 56 Rinse Water ... 56 Ethylene oxide gas sterilization ... 57 Steam sterilization (autoclaving) of accessories ... 58

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6.4

Cleaning of CO2 regulation unit, cylinder hose, and gas pipeline adapter ... 59

6.5

Storing CO2 regulation unit, cylinder hose, and gas pipeline adapter ... 60

6.6

Cleaning the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 61

6.7

Disinfecting the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 62 UCR INSTRUCTION MANUAL

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6.8

Rinsing the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 63

6.9

Sterilization of the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 64

6.10 Storing the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra low flow gas tube (MAJ-1816) ... 66 6.11 Care and storage of the water container (MAJ-902) ... 66 6.12 Disposal ... 66

Chapter 7 Troubleshooting ... 67 7.1

Troubleshooting guide ... 67 Endoscopic CO2 regulation unit (UCR) ... 67

7.2

Returning the endoscopic CO2 regulation unit for repair ... 68

Appendix ... 69 Combination equipment ... 69 System chart ... 69

Transportation, storage, and operating environments ... 71 Specifications ... 71 EMC information ... 75

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Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the instrument at the locations shown below. If the labels or symbols are missing or illegible, contact Olympus.

 UCR CO2 regulation unit Front panel

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

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Labels and Symbols

Rear panel

CE marking

Crossed-out wheeled bin’ symbol Only the exclusive cable can be connected.

Timer

Potential equalization terminal Electrical rating plate Product name, rated voltage and frequency are shown. ENDOSCOPIC CO2 REGULATION UNIT MODEL: OLYMPUS UCR INPUT: 100 – 240V

SN

50/60Hz 40VA

Serial number plate

Fuse rating FUSES T2AH250V

CO2 gas inlet Manufacturer name

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Only the exclusive hose and adapter can be connected.

Labels and Symbols

 Cylinder hose (PIN, MAJ-1080)

Caution, refer to instructions.

 Cylinder hose (DIN, MAJ-1081), Cylinder hose (ISO, MAJ-1082)

Caution, refer to instructions.

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Labels and Symbols

 Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), Extra low flow gas tube (MAJ-1816)

Caution, refer to instructions.

Gas tube ID indications on tags are shown as follows: “HIGH”

(MAJ-1741)

“MED”

(MAJ-1742)

“LOW”

(MAJ-1816)

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use The endoscopic CO2 regulation unit has been designed to be used with Olympus gastrointestinal endoscopes, lens cleaning sheath for surgical endoscope and ancillary equipment for CO2 gas and water feeding. Do not use the endoscopic CO2 regulation unit for any purpose other than its intended use.

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

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Important Information - Please Read Before Use

 User qualifications If there is an official standard on user qualifications to perform endoscopy, endoscopic treatment, and endoscopic surgery that is defined by the medical administration or other official institutions, such as academic societies on endoscopy or endoscopic surgery, follow that standard. If there is no official qualification standard, 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 internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy, endoscopic treatment, and endoscopic surgery following guidelines set by the academic societies on endoscopy or endoscopic surgery, etc., and considering the difficulty of endoscopy, endoscopic treatment, and endoscopic surgery. This manual does not explain or discuss endoscopic procedures.

 Instrument compatibility Refer to the “ System chart” on page 69 to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. This instrument complies with EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument that complies with EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

 Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.

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Important Information - Please Read Before Use

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

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

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

Indicates additional helpful information.

 Dangers, warnings, and cautions Follow the dangers and warnings given below when handling this instrument. This information is to be supplemented by the dangers and warnings given in each chapter.

DANGER • As a TYPE BF applied part, this endoscopic CO2 regulation unit must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following points:  Never apply the endoscope connected to this endoscopic CO2 regulation unit to the heart or any area near the heart.  Never allow the hand instruments or another endoscope applied to or near the heart to come in contact with an endoscope connected to this endoscopic CO2 regulation unit.

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Important Information - Please Read Before Use

DANGER • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock.  When the endoscopic CO2 regulation unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient.  Keep fluids away from all electrical equipment. If fluids are spilled on or into the endoscopic CO2 regulation unit, stop operation of the unit immediately and contact Olympus.  Do not prepare, inspect or use this CO2 regulation unit with wet hands. • Never install and operate the endoscopic CO2 regulation unit in the following locations. An explosion or fire may result because the endoscopic CO2 regulation unit is not explosion-proof.  The concentration of oxygen is high.  Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.  Flammable gases are present in the atmosphere.  Flammable liquids are nearby. • Supply medical grade CO2 gas only. Never use other kinds of gas. Using gases other than CO2 gas may result in fire, poisoning, complications, etc.

WARNING • If the endoscopic CO2 regulation unit is used with the upper/lower gastrointestinal endoscopes, use it only for CO2 gas/water feeding within the upper/lower digestive tract. If the endoscopic CO2 regulation unit is used with the lens cleaning sheath, use it only for CO2 gas feeding/spraying toward the objective lens of the endoscope within the thoracic and abdominal cavities including female reproductive organs. • If the endoscopic CO2 regulation unit is used with the lens cleaning sheath, do not feed spray/CO2 gas to an open vessel directly. Do not use the lens cleaning sheath near an open vessel or do not press the distal tip of the lens cleaning sheath against tissues. Otherwise, gas embolism may result.

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Important Information - Please Read Before Use

WARNING • To prevent electrical shock hazards, the housing of the endoscopic CO2 regulation unit must be grounded. Always connect the power cord plug to a properly grounded hospital grade AC outlet (wall mains outlet). Properly grounded wall mains outlet

Power cord plug

Figure 1 • To ensure electrical safety, do not use this instrument with any of the following medical electrical equipment.  Medical electrical equipment that has not been approved for safe use in combination with this instrument.  Medical electrical equipment that has not been verified to be safe with respect to leakage current, etc. • To ensure that the operation can be completed without complication in case of a malfunction, prepare a spare endoscopic CO2 regulation unit as a backup.

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Important Information - Please Read Before Use

WARNING • Occurrences of hypercapnemia through CO2 absorption have been reported in medical literature, primarily during laparoscopic surgery. Careful clinical review prior to the procedure should be undertaken by trained medical personnel to eliminate this potential risk. To avoid complications, monitor patient parameters such as PCO2, electrocardiogram, body temperature, etc., while using the endoscopic CO2 regulation unit.  Reference 1)

Norman J, Atkinson SA: The effect of cardiac sympathetic blockade on the relationship between cardiac output and carbon dioxide tension in the anesthetized dog. Br J Anaesth 42: 592 – 602, 1970

2)

Scott, D. B. and Julian, D. G.: Observations on cardiac arrhythmias during laparoscopy. Br. Med. J.,1: 411 – 413, 1972.

3)

Smith, I., Benzie, R. J., Gordon, N. L. M., et al.: Cardiovascular effects of peritoneal insufflation of carbon dioxide for laparoscopy. Br. Med. J., 3: 410 – 411, 1971.

4)

Lenz, R. J., Thomas, T. A. and Wilkins, D. G.: Cardiovascular changes during laparoscopy: Studies of stroke volume and cardiac output using impedance cardiography. Anaesthesia, 31: 4 – 12, 1976.

5)

Ishizaki, Y., Bandai, Y., Shimomura, K., et al.: Safe intra-abdominal pressure of carbon dioxide pneumoperitoneum during laparoscopic surgery. Surgery, 114: 549 – 554, 1993.

• The endoscopic CO2 regulation unit has no function of intraluminal pressure measurement and automatic control. • Always use the provided power cord with the endoscopic CO2 regulation unit. Using another power cord may result in equipment failure or power cord burns. The provided power cord has been designed exclusively for the endoscopic CO2 regulation unit and should not be used with other equipment. • Be sure to turn the endoscopic CO2 regulation unit OFF after use. If it is left ON after examination/operation, an accidental contact with the start/stop switch may start gas supply. This will not only empty the CO2 gas cylinder but may also increase the CO2 concentration in the environment. • Use the endoscopic CO2 regulation unit only under the conditions described in “Transportation, storage, and operating environments” on page 71. Use under other conditions may not only impair the normal performance, but may also result in equipment damage. • Prepare spare CO2 gas cylinders for quick replacement if the cylinder used during the procedure should run out.

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Important Information - Please Read Before Use

CAUTION • Do not use a pointed or hard object to press the buttons on the front panel. This may damage the instrument. • To prevent equipment damage, do not use it in a dusty environment. • Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference. • Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable 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 instrument, or shielding the location.

 Use in combination with the upper/lower gastrointestinal endoscope WARNING • Over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism and/or perforation. • Anytime you observe an irregularity in the endoscopic CO2 regulation unit, immediately stop using the endoscopic CO2 regulation unit and withdraw the endoscope from the patient slowly as described in the endoscope’s instruction manual. • The CO2 gas is normally emitted through the small hole in the endoscope’s air/water valve. Persons in the operating room may be affected if the CO2 concentration in the operating room increases. Be sure to ensure ventilation of the room. • During use, always stop the device like light source from supplying air. If “Stop” is not selected, a mixture of air and CO2 may be supplied into the patient body. • To prevent the water in the water feed tank from flowing into this unit through the gas tube, install this unit in a position as high as possible compared to the water feed tank.

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Important Information - Please Read Before Use

 Use in combination with the lens cleaning sheath WARNING • Anytime you observe an irregularity in the endoscopic CO2 regulation unit, immediately stop using the endoscopic CO2 regulation unit and withdraw the endoscope from the patient slowly as described in the instruction manual for the lens cleaning sheath. • To prevent gas embolism caused by intra-abdominal over-pressurization from the combined use of the lens cleaning sheath and a laser device, argon-enhanced coagulator, or other gas supply devices, carefully read and understand the following before using in case the insufflator is used in operation:  When performing endoscopic operation using a lens cleaning sheath and a laser device, argon-enhanced coagulator, or other gas supply devices simultaneously, both instruments become a source of supply for gas. Accordingly, the desired pressure in the abdomen is reached in a shorter time than when a lens cleaning sheath is used alone. In these cases, be careful that the cavity does not become over-pressurized. The laser device, argon-enhanced coagulator, and other gas supply devices are not equipped to monitor the cavity pressure (automatic termination of insufflation, warning light or alarm). Although the insufflator is equipped with these functions, it does not always prevent gas embolism inasmuch as this depends on the patient and the condition of the infected area. We ask that the physicians make a suitable judgment from a professional standpoint himself.  If the insufflator emits a caution (caution light or alarm) for cavity over-pressurization, quickly open the stopcock or valve of the trocar. Then, reduce the amount of outflow from the laser device, argon-enhanced coagulator, or other gas supply device. If use is continued while the alarm sounds, there is a risk of gas embolism due to cavity over-pressurization. • Be careful not to feed CO2 too much during CO2 gas feed or spraying. Excessive CO2 gas feed/spraying may cause pain to the patient and/or gas embolism. Reduce the use of CO2 gas feed and spraying at the requisite minimum level. • In case the insufflator is used in operation, open the trocar cannula stopcock if the pressure in the abdomen exceeds the set pressure by more than 5 mmHg. • Do not attempt to insufflate the abdominal cavity using the lens cleaning sheath. Otherwise, patient injury and/or gas embolism may result. • Do not use the endoscopic CO2 regulation unit in combination with other than the compatible lens cleaning sheath (with the MAJ-1345, MAJ-1537, or MAJ-659, for example). Otherwise, CO2 gas is fed continuously and patient pain and gas embolism can result.

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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 instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus.

 Endoscopic CO2 regulation unit (UCR)

Endoscopic CO2 regulation unit (UCR)

 Accessories

Power cord

Water container (MAJ-902)*1

Nut cover

Instruction manual

Gas tube (MAJ-1741)*1

*1 When the endoscopic CO2 regulation unit is combined with the lens cleaning sheath, the water container (MAJ-902) and Gas tube (MAJ-1741) are not used.

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1.2 Optional items

1.2

Optional items

The following Olympus items are optional items, which may be purchased separately according to the examination technique and/or patient condition. • Low flow gas tube (MAJ-1742)

Ch.1

• Extra low flow gas tube (MAJ-1816) The following Olympus items are optional items, which may also be purchased separately. • Cylinder hose for UHI-3 (PIN, MAJ-1080) • Cylinder hose for UHI-3 (DIN, MAJ-1081) • Cylinder hose for UHI-3 (ISO, MAJ-1082) • Medical gas pipeline adapter for UHI-3 (NIST, MAJ-1084) • Medical gas pipeline adapter for UHI-3 (DISS, MAJ-1085) The following non-Olympus item may also be purchased separately. • Medical gas pipeline hose For other equipment combinations, refer to the “ System chart” on page 69.

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1.2 Optional items

 Low flow gas tube (MAJ-1742), Extra low flow gas tube (MAJ-1816)

Ch.1

Low flow gas tube (MAJ-1742), Extra low flow gas tube (MAJ-1816)

 Cylinder hose for UHI-3 (PIN, MAJ-1080)*1

Hose for cylinder

Cap

Wrench

Replacement procedure for packing (O-ring)

*1 The endoscopic CO2 regulation unit is compatible with the cylinder hose for UHI-3 (MAJ-1080).

The wrench is supplied for installation of the unit by an Olympus sales representative or service engineer only. The wrench should be returned to Olympus directly after installation.

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