Maintenance Manual
48 Pages
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MAINTENANCE MANUAL HIGH FLOW INSUFFLATION UNIT
UHI-3
ISSUE9 2016/03 148P-1827
UHI-3
1. Introduction Repair and maintenance of this product requires highly specialized knowledge and techniques. We recommend that you contact an Olympus service center in your area if a problem develops with the product. If repairs or modifications are made by personnel not authorized by Olympus, the warranty is void, and Olympus shall not be liable for damage that occurs to or as a result of use of the modified product.
2. Applicable Unit • HIGH FLOW INSUFFLATION UNIT UHI-3 • HIGH FLOW INSUFFLATION UNIT UHI-3
120V 220V
3. Copyright © 2006 Olympus Medical Systems Corp. All rights reserved.
Unauthorized reproduction or distribution in part or in whole is prohibited.
4. Trademarks OLYMPUS is a registered trademark of the Olympus Corporation. The company names, product names, and proprietary technical terms in this document are the trademarks or registered trademarks of their respective owners.
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CONTENTS
UHI-3
CONTENTS Chapter 1: Product Outline ... 1-1 1
Features ... 1-1
2
Specifications... 1-3
3
Figures and Tables ... 1-11
4
Restrictions ... 1-14
5
Name and Function of Each Part... 1-16
6
System Diagram ... 1-22
Chapter 2: Specification... 2-1 Chapter 3: Installation and Connection ... 3-1 Chapter 4: Care, Storage and disposal... 4-1 Chapter 5: Inspection ... 5-1 1
Inspection Check Sheet... 5-1
Chapter 6: Safety check ... 6-1 1
Measuring exterior leakage current ... 6-1
2
Measuring ground leakage current ... 6-1
3
Measuring grounding resistance... 6-2
4
Inspection Card ... 6-3
Chapter 7: Block Diagram... 7-1 Chapter 8: Trouble shooting... 8-1
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UHI-3
Chapter 1:Product Outline 1. Features The UHI-3 is a pneumoperitoneum system designed to provide a space and viewing field required for laparoscopic surgery and observation by supplying CO2 gas to the peritoneal cavity, then automatically removing waste CO2 and fumes. (1) Adjustable flow rate The UHI-3 offers three (3) supply modes: “High,” “Medium,” and “Low,” selectable according to the type of equipment used and the amount of CO2 gas leaking from within the peritoneal cavity. You can select from two desired flow rates within each mode: 20 to 35 L/min in High mode, 1.1 to 19 L/min in Medium mode, and 0.1 to 1.0 L/ min in Low mode. (2) Peritoneal cavity pressure The UHI-3 allows you to select a peritoneal cavity pressure within the range of 3 and 25 mmHg. (3) Supply pressure display The supply pressure is shown by a LED meter. Note that the peritoneal-cavity pressure and the preset flow rate are displayed as green digits, while the actual flow rate is displayed as red digits and as a LED meter. Also note that the total gas flow amount is displayed as red. (4) Warnings The UHI-3 warns the user of excessive pressure if the actual peritoneal cavity pressure exceeds the preset pressure by 5 mmHg or more. Note that the tube clogging warning is activated to inform the user if the tube or connected equipment is clogged or if the CO2 gas is being supplied to an extremely confined space. (5) Relief function The UHI-3 opens the internal valve to relieve peritoneal cavity pressure if the actual pressure exceeds the preset pressure by 5 mmHg or more. You can use the menus displayed on the front panel to disable this function. (6) Automatic removal of CO2 gas The UHI-3 automatically starts removing CO2 gas to reduce peritoneal cavity pressures to the preset level in the event that the actual pressure exceeds the preset pressure by 5 mmHg or more for 10 seconds or more when connected to the facility’s suction equipment. (This makes it easy to maintain peritoneal cavity pressure at the preset level.) (7) Removal of fumes CO2 gas is supplied and removed in a coordinated fashion when the UHI-3 is used in conjunction with the MH-317 foot switch (optional) and when it is connected to the facil-
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Product Outline
UHI-3
ity’s suction equipment, allowing for gas removal while maintaining peritoneal cavity pressure at the preset level. This feature also makes it easy to obtain the required visual field. This feature works on removing fumes during radio-frequency cauterization. (8) Interlocked function 1 The UHI-3 can automatically remove fumes in accordance with the output when equipped with the MAJ-529 exhaust unit (optional; not yet marketed in Japan and OAI) and used in conjunction with the SonoSurg, the UES-20, or the UES-30. (9) Interlocked function 2 The UHI-3 can automatically remove fumes when equipped with the MAJ-877 fumeremoval cable (optional) and used in conjunction with the SonoSurgG2. (10) Wall piping The UHI-3 can use CO2 gas from a facility outlet when equipped with the MAJ-1084 (NIST) or MAJ-1085 (DISS) wall-piping hose adapter. (11) Filter The UHI-3 can filter out bacteria and particles in the gas line and prevent body fluids from flowing back toward the patient (thus preventing contamination of the gas line) when used in conjunction with the filter (manufacturer: PALL, model: ORO1H). (available from OLYMPUS distributors rather than from OLYMPUS directly)
Product Outline
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2. Specifications 2-1
Applicable equipment • Applicable gas (1) Medical-grade CO2 gas can be used. (2) A high-pressure hose or wall-piping hose must be used to connect to the gas canister. • Lure lock connector Connector for pneumoperitoneum (CO2 -injection) tube: 00103 Connector for suction tube: Included in the MAJ-591. • High-pressure hose MAJ-1080 (PIN), MAJ-1081 (DIN), MAJ-1082 (ISO), MH-455 (Y-shaped), TI-AI imaging trolley (T-shaped high-pressure hose) • Wall-piping adapter MAJ-1084 (NIST), MAJ-1085 (DISS) • Pneumoperitoneum tube MH-397, MAJ-590 • Suction tube MAJ-591 • Foot switch MH-317 • Veress needle, trocar OLYMPUS Veress needle, trocar • Exhaust unit MAJ-529 (not yet marketed in Japan and OAI) • Filter Manufactured by PALL, model: ORO1H (available from OLYMPUS distributors rather than OLYMPUS directly) • Exhaust fume cable MAJ-877
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Product Outline
UHI-3
2-2
Functions related to supply pressure • Display method The supply pressure is displayed via the green and red LEDs on the supply pressure LED meter. (See section 3-1, "Supply pressure LED meter" in section 3, "Figures and Tables.") • Display range 0 to 4.5 MPa Note that the units are not shown. Instead, the pressure is displayed in a 5-step LED meter. • Warnings (in the event of insufficient supply pressure) (1) The beeper sounds for one second if the supply pressure is insufficient. (2) After the first beep, the beeper sounds each time the supply pressure drops by a predetermined amount. (3) The beeper sounds for three seconds if there is no more supply pressure drops to zero or if the software goes into stop mode.
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Peritoneal cavity pressure control function • Control The UHI-3 stops supplying CO2 gas when the peritoneal cavity pressure reaches the preset level and resumes CO2 gas supply if the peritoneal cavity pressure drops 1 mmHg below the preset level. • Display (1) Display method a)
LED meter of peritoneal cavity pressure (See section 3-1, "Supply pressure LED meter" in section 3, "Figures and Tables.") The number of LEDs that light up is determined by the proportion of the actual peritoneal cavity pressure to the preset pressure. When the actual pressure is 100% of the preset pressure, nine (9) green LEDs light up, while none of the green LEDs lights up if the actual pressure is 0% of the preset pressure. The number of green LEDs that lights up changes proportionally within this range. If excessive pressure is present (when the actual pressure exceeds the preset pressure by 4.5 mmHg or more) three red LEDs light up. At this time, the displayed preset pressure figure flashes.
b)
Peritoneal cavity pressure indicator (7-segment LED, red) Display range: 0 to 50 mmHg Units: 1 mmHg Measurement error: ±2.7 mmHg (when the preset pressure is attained)
c)
Preset pressure indicator (7-segment LED, green) Display range: 3 to 25 mmHg Units: 1 mmHg
Product Outline
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• Setting the peritoneal cavity pressure (1) Setting level (units) You can set the peritoneal cavity pressure within a range from 3 to 25 mmHg in units of 1 mmHg. (2) Changing the setting Use the peritoneal cavity pressure setting switch to change the setting. a)
Any pressure level between 3 and 25 mmHg can be specified.
b)
Each time you press the switch, the pressure setting increases or decreases by 1 mmHg.
c)
As part of safety design, you need to press the switch three times to increase the pressure setting from 20 to 21 mmHg.
(3) Storing the setting At power-on, the pressure setting assumes the value selected when the power was previously turned off. Note that as part of the safety design, the pressure setting defaults to 20 mmHg if a value of 21 mmHg or greater is specified. (4) Relief mode You can turn relief mode on or off by turning the power on while holding down the Reset switch for three seconds. The relief-mode indicator lamp is lit when relief mode is on. • Warnings (1) Excessive peritoneal cavity pressure The UHI-3 stops supplying CO2 and initiates the following operations if the actual peritoneal cavity pressure exceeds the preset pressure by 5 mmHg or more: a)
The beeper sounds and the peritoneal cavity pressure warning lamp lights.
b)
If the condition described in “a)” persists for ten (10) seconds or more, the UHI-3 starts removing CO2 gas. The UHI-3 stops suction when the peritoneal cavity pressure drops to the preset level.
c)
With relief mode turned on, the UHI-3 opens the relief valve to relieve the pressure until it drops to the preset level. The UHI-3 does not open the relief valve if the relief mode is off.
(2) Tube clogging If a tube is clogged or if CO2 gas is supplied to an extremely confined space (such as under the skin), the UHI-3 stops the supply of CO2 gas. At this time, the tube-clogging warning lamp lights and the beeper sounds. The lamp remains lit and the beeper continues to sound until they are reset.
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Product Outline
UHI-3
2-4
Flow rate control function • Control (1) The UHI-3 supplies CO2 gas at the preset rate when the actual peritoneal cavity pressure is far enough below the preset level. (2) The UHI-3 gradually reduces the flow rate as the actual peritoneal cavity pressure approaches the preset level. (3) The UHI-3 stops the supply of CO2 gas when the actual pressure reaches the preset level. • Display (1) Supply pressure LED meter (green LEDs) See section 3-1, "Supply pressure LED meter" in section 3, "Figures and Tables." The CO2 gas-flow rate (instantaneous flow rate) is displayed in green. (All LEDs up to the instantaneous flow rate light up.) (2) Preset flow rate indicator (7-segment LED, green) The flow rate setting is displayed in green. The following table shows the flow rate for each supply mode: Supply mode
Flow rate (L/min)
High
20 to 35
Medium
1.1 to 19
Low
0.1 to 1.0
Units:
In units of 0.1 L/min for 0 to 2 L/min In units of 1 L/min for 2 to 35 L/min
(3) Flow rate indicator (measured flow rate) The average flow rate is displayed by the red 7-segment LED. • Setting the flow rate (1) Increments You can specify the flow rate in the following increments in each supply mode: a)
High and Medium: Increments of 1 L/min Note that the flow rate can be specified in increments of 0.1 L/min in the 1.1 - 2 L/ min range.
b)
Low: Increments of 0.1 L/min
(2) Changing the setting
Product Outline
a)
Use the Supply Mode Selector switch to select a desired supply mode.
b)
Use the Flow Rate Setting switch to change flow rates.
c)
You can change supply modes during CO2 gas supply.
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(3) Storing the settings a)
“Low” is always selected as supply mode at power-on.
b)
The settings selected for each supply mode are stored when the power is turned off.
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Total amount display function • Display method The total amount of flowed CO2 gas is displayed by the total-flow indicator (red 7-segment LED). • Display range and units (1) In units of 0.1 L for 0.0 to 19.9 L (2) In units of 1 L for 20 to 999 L (Returns to “0.0” after “999”) • Resetting the value You can reset the displayed value by pressing the Reset switch (i.e., 0.0L).
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Fume removal function • Turning the function ON/OFF (1) CO2 gas supply and suction work in coordinated fashion when you switch on the foot switch. Fume removal stops if you switch off the foot switch. (2) CO2 gas supply and suction work in coordinated fashion in response to the output when the UHI-3 is connected to the SonoSurgG2 using the MAJ-877 exhaust fume cable. CO2 gas removal stops five (5) seconds after the output has stopped. (3) You can turn the fume-removal function on or off remotely using the Alpha communications protocol. • Gas-flow rate during fume removal
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Flow rate setting
Flow rate
10 L/min or more
Fixed at 10 L/min
6 to 9 L/min
Same as setting
1.1 to 5 L/min
Fixed at 5 L/min
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Product Outline
UHI-3
• Limitations The fume removal function is not activated: (1) if “Low” is selected as the supply mode; (2) if CO2 supply is stopped (This is the case where a warning is given as a result of peritoneal cavity pressure or tube clogging); (3) if the peritoneal cavity pressure drops below 3 mmHg; or (4) if the suction tube is not connected.
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Starting/stopping CO2 gas supply • Starting CO2 gas supply When you press the gas-start switch, the UHI-3 (1) initiates CO2 supply (along with activation of functions relating to excessive peritoneal cavity pressure and tube-clogging warnings, as well as opening of the relief valve); (2) controls automatic CO2 suction and fume removal (optional); and (3) displays the canister pressure and the total amount of flowed CO2 gas supplied. • Stopping CO2 gas supply When you press the stop switch, the UHI-3 (1) stops CO2 supply, automatic CO2 suction, and fume removal (optional) (the excessive peritoneal cavity pressure warning remains functional); (2) displays the settings, the canister pressure, and the total amount of CO2 that has flowed; and (3) measures and displays the peritoneal cavity pressure.
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Data communication Data communication is performed in accordance with the 7-conductor Alpha communications protocol.
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Making connections • Pneumoperitoneum tube (1) Connection with the main unit Connect the tube to the metal fitting of the CO2 outlet. (2) Connection with the Veress needle or trocar Use a lure lock connector for connection.
Product Outline
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(3) When using the filter, connect a junction tube to the metal fitting of the CO2 outlet and insert the tube between the pneumoperitoneum tube and the junction tube. • Suction tube (1) Connection with the main unit Allow the suction tube to be pinched by the pinch valve provided for controlling CO2 suction. (2) Connection with trocar Use a lure lock connector for connection. (3) Connection with suction source (Connect as per the suction specifications for the facility in question. Connect with a trap bottle.) Put the tube on the metal fitting of the suction bottle. Use a Y-connector and extension tube between the suction tube and the suction bottle, as necessary. • Foot switch Connect the foot switch to the foot-switch connector provided on the rear panel. • Communication cable Connect the communications cable to the system port provided on the rear panel. • High-pressure hose (CO2 canister) (1) The following three adapters are available for connection between the high-pressure hose and the canister: a)
PIN INDEX (JIS B8246 high-pressure gas container valve, model C1) (ISO 407)
b)
DIN (DIN 477 Anschl. No. 6. W21.8-14)
c)
ISO (ISO 5145 W27 16-16)
• Wall-piping hose (1) Connection between the main unit and the wall-piping hose adapter Male sheet union joint with parallel internal thread for piping: Nominal size model C-5 (2) Connection between the wall-piping hose adapter and the wall-piping hose a)
NIST (MAJ-1084)
b)
DISS (MAJ-1085)
• Fume removal cable (MAJ-877) Connect one end of the cable to the system port provided on the rear panel and the other end to the specified connector on the therapeutic equipment.
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Product Outline
UHI-3
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Safety • Sterilization (1) Exterior of the enclosure The enclosure exterior can be cleaned with rubbing alcohol and water. (2) Pneumoperitoneum tube and suction tube These tubes can be steam-sterilized under pressure and can also be sterilized with ethylene oxide gas.
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Other • Weightþ 10.0 kg • External dimensions 295 mm (W) x 340 mm (D)x 150 mm (H) (excluding protrusions) 295 mm (W) x 340 mm (D) x 162 mm (H) (max. dimensions) • Power cord 100 V: Cord set with 3-conductor cord and hospital-grade plug 200 V: Cord set with 3-conductor cord (with no plug)
Product Outline
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3. Figures and Tables 3-1
Supply pressure LED meter Condition for lighting (pressure) Green
4.5 MPa ≦ Measured value
Green
3.5 MPa ≦ Measured value < 4.5 MPa
Green
2.5 MPa ≦ Measured value < 3.5 MPa
Green
1.5 MPa ≦ Measured value < 2.5 MPa
Green
0 MPa ≦ Measured value < 1.5 MPa
Red
0 MPa and when the supply pressure decreased*
* In supply pressure decreased, the software “stops” after determining that the pressure is too low (following initiation of the CO2 supply) and that CO2 cannot be supplied properly.
Supply pressure LED meter
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Product Outline
UHI-3
3-2
LED meter of peritoneal cavity pressure A: Measured pressure (mmHg) B: Preset pressure (mmHg) Condition for lighting (pressure)
Red
B + 4.5 ≦ A
Red
B + 3.0 ≦ A < B + 4.5
Red
B + 1.5 ≦ A < B + 3.0
Green
17/18 x B ≦ A < B + 1.5
Green
15/18 x B ≦ A < 17/18 x B
Green
13/18 x B ≦ A < 15/18 x B
Green
11/18 x B ≦ A < 13/18 x B
Green
9/18 x B ≦ A <11/18 x B
Green
7/18 x B ≦ A < 9/18 x B
Green
5/18 x B ≦ A < 7/18 x B
Green
3/18 x B ≦ A < 5/18 x B
Green
1/18 x B ≦ A < 3/18 x B
LED meter of peritoneal cavity pressure
Product Outline
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Flow rate LED meter Condition for lighting
(Unit: L/min)
25.0 L/min ≦ Measured flow rate 17 ≦ Measured flow rate < 25 13 ≦ Measured flow rate < 17 10 ≦ Measured flow rate < 13 7.5 ≦ Measured flow rate < 10 5.8 ≦ Measured flow rate < 7.5 4.2 ≦ Measured flow rate < 5.8 2.8 ≦ Measured flow rate < 4.2 1.5 ≦ Measured flow rate < 2.8 1.0 ≦ Measured flow rate < 1.5 0.5 ≦ Measured flow rate < 1.0 0.25 ≦ Measured flow rate < 0.5 None of the LEDs lights if the measured value < 0.25 L/min.
Flow rate LED meter
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Product Outline
UHI-3
4. Restrictions (1) The UHI-3 must be used in medical facilities under the supervision of doctors. (2) Never use the UHI-3 where flammable vapors occur. (3) To provide adequate safety, the UHI-3 exterior must be grounded. (4) Power supply Outside Japan (1EU, 3EAIU, 4SU)
Japan (1JU)
Rated voltage
100-240 V
100 V
Power input
150 VA
0.7 A
Frequency
50/60 Hz
Voltage fluctuation
±10% max.
(5) Operating conditions (temperature and humidity in operating room) Ambient temperature: 10 to 40°C Relative humidity: 30 to 85% Atmospheric pressure: 700 to 1060 hPa (6) Classification as electrical equipment for medical use The UHI-3 is classified as CF equipment with regard to the degree of protection against electrical shock. (7) Type of protection against electrical shock Class I (8) Only CO2 gas for medical use may be used. (9) Piping of gas for medical use Outside Japan (1EU, 3EAIU, 4SU) Supply pressure
Upper limit
1400 kPa (pressure defined under ISO 7396)
Lower limit
343.2 kPa
Flow rate
Product Outline
Japan (1JU) 392.3 ± 49 kPa (pressure defined under JIS T7101)
40 L/min or more (calculated based on conditions of 0°C, 101.3 kPa)
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(10) Suction equipment Suction equipment must meet the following requirements, as defined under JIS T7101 (gas-piping equipment for medical use): a)
Maximum flow rate at the terminal equipment of the piping 40 L/min or more (calculated based on conditions of 0°C, 101.3 kPa)
b)
Suction pressure -39.9 to 53.2 kPa (-300 to 400 mmHg: reference range)
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Product Outline
UHI-3
5. Name and Function of Each Part 5-1
UHI-3 High-speed pneumoperitoneum system
5-1-1
Front panel (8) Stop switch
(7) Metal fitting (for the CO2 outlet)
(9) Gas-start switch
(5) Reset switch (6) Pinch valve
(1) Power switch (2) Peritoneal cavity pressure setting switches
(3) Supply-mode selector switch
(4) Flow rate setting switches
(1) Power switch Switch on this switch to turn on power. The power indicator lamp above the power switch lights at the same time. (2) Peritoneal cavity pressure setting switches Use these switches to set the peritoneal cavity pressure within the range of 3 to 25 mmHg. Press the switch three times to increase the pressure setting from 20 to 21 mmHg. (3) Supply-mode selector switch Use this switch to select the CO2 supply mode. The mode toggles from Low to Medium, Medium to High, and High to Low as you press this switch repeatedly.
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(4) Flow rate setting switches Use these switches to specify the flow rate in each CO2 supply mode. The range of flow rates available in each mode is as follows: Low: 0.5 or 1.0 L/min Medium: 1.5 to 19 L/min High: 20 to 35 L/min (5) Reset switch Use this switch to reset the total flow indicator to 0.0 L. Note that you can turn the relief mode on or off by switching on the power switch while holding down the reset switch. (6) Pinch valve (for CO2 suction control) Connect the suction tube to this valve. (7) Metal fitting (for the CO2 outlet) Connect the pneumoperitoneum tube or junction tube to this outlet. (8) Stop switch Press this switch to stop CO2 supply. (9) Gas-start switch Press this switch to start CO2 supply. At this time, fume removal and automatic CO2 suction functions are also enabled.
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Product Outline