MR860AEU HumiGard Instructions for Use Rev C Dec 2011.pdf
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SURGICAL HUMIDIFICATION SYSTEM
MR860AEU
Surgical Humidification System Instructions for Use
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Section
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English
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(Chinese Simplified)
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dn
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de
Deutsch
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es
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fr
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Greek
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Table of Contents
1
Before You Start
A2
2
Intended Use
A2
3
Operator Profile
A2
4
Warnings
A2
4.1
General Warnings
A2
4.2
Warnings for Laparoscopic Procedures
A2
4.2.1
ST310 Laparoscopic Humidification Kit Only
A2
4.2.2
RT350 Humidified Insufflation Kit Only
A2
4.3
Warnings For Open Procedures
A3
5
General Precautions
A3
6
Device Description
A4
7
Accessory Description
A4
7.1
900ST100 Adaptor
A4
7.2
Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
A5
7.3
Laparoscopic Procedures – RT350 Humidified Insufflation Kit
A6
7.4
Open Procedures – ST300 Open Surgery Humidification Kit with VITA-diffuser™
A7
8
Initial Humidifier Set-up Instructions
A7
9
Operating Instructions
A8
9.1
Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
A8
9.2
Laparoscopic Procedures – RT350 Humidified Insufflation kit
A10
9.3
Open Procedures – ST300 Open Surgery Humidification Kit with VITA-diffuser™
A12
10 Front Panel Indicators and Troubleshooting
A14
11 General Cleaning Instructions
A15
12 Routine Maintenance, Servicing and Calibration
A15
13 Device and Accessory Disposal Instructions
A15
13.1
Humidifier and Adaptor Disposal Instructions
A15
13.2
Accessory Disposal Instructions
A15
14 Specifications
A16
14.1
F&P HumiGard™ Surgical Humidifier
A16
14.2
Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
A16
14.3
Laparoscopic Procedures – RT350 Humidification Kit
A16
14.4
Open Procedures – ST300 Open Surgery Humidification Kit
A17
15 Symbol Definitions
A17
16 Approved Accessories
A17
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Instructions for Use
MR860AEU
en
1. Before You Start
Please read this manual carefully before use and save these instructions for future reference. If the
device or any accessories are not operating correctly, please contact your Fisher & Paykel Healthcare
office (as detailed on the back cover) or applicable distributor.
2. Intended Use
For use in warming and humidifying surgical insufflation gas.
Laparoscopic Procedures
Intended for patients of all ages undergoing laparoscopic procedures where carbon dioxide (CO2 )
insufflation gas is used.
Open surgery Procedures
Intended for patients of all ages undergoing open abdominal or cardiothoracic surgical procedures
where CO2 insufflation gas is used.
3. Operator Profile
To be operated by a healthcare provider with experience in the set-up of surgical equipment,
including the handling of sterile items. The user must read these user instructions and the user
instructions of associated accessories before use.
4. Warnings
4.1 General Warnings
• The ST310 Laparoscopic Humidification Kit, RT350 Humidified Insufflation Kit and the ST300
Open Surgery Humidification Kit are intended for single use. Reuse may result in transmission of
infectious substances, interruption of treatment, serious harm or death. Incinerate consumables
after use.
• To ensure sterility of the humidified insufflation tube, inspect sterile packaging for damage before
use. Discard if damaged.
• To avoid the risk of electric shock, this equipment must be connected to a mains supply with
protective earth.
To avoid excess energy in the output gas do not:
• Use the system with preconditioned CO2 gas.
• Fill the humidification chamber with water in excess of 37 °C.
• Place surgical drapes over the humidified insufflation tube.
• Coil the humidified insufflation tube.
• Do not use gases other than CO2.
4.2 Warnings for Laparoscopic Procedures
• To prevent air embolism, purge the system of air using CO2 before insufflation.
• For safe and effective use do not exceed the insufflator maximum set flow rate (≤ 45 L/min).
• To avoid inaccurate pressure readings on the insufflator, ensure insufflators used are regularly
serviced and/or calibrated according to the manufacturer’s instructions.
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4.2.1 ST310 Laparoscopic Humidification Kit Only
• To ensure stable and accurate pressure readings on the insufflator when using the Veress needle,
ensure that the humidification chamber is filled to the recommended water level ~ 180 mL.
4.2.2 RT350 Humidified Insufflation Kit Only
• To ensure stable and accurate pressure readings on the insufflator when using the Veress needle,
use the Veress bypass connector.
• To prevent any pressure fluctuations with the Conmed-Linvatec GS1002 insufflator, use
conventional insufflation tubing for initial creation of pneumoperitoneum when using the Veress
needle.
4.3 Warnings For Open Procedures
• To ensure efficient de-airing of the wound only use the system with an approved gas diffuser.
The VITA-diffuser™ manufactured by Cardia Innovation AB is approved for use with the ST300
Open Surgery Humidification Kit.
• For correct use of the VITA-diffuser™ refer to the VITA-diffuser™ Instructions for Use
(REF VdBXYYYYMM) or the CarbonVITA™ Instructions for Use (CVBXYYYYMM).
• For safe and effective use do not exceed the maximum flow rate (≤ 15 L/min).
5. General Precautions
To ensure patient safety, optimal therapy and performance:
• Only use accessories approved by Fisher & Paykel Healthcare.
• Do not use the serial port when the humidifier is in patient use as this may cause electromagnetic
interference with other equipment.
• Always disconnect the power supply before servicing. Failure to do so may compromise electrical
safety.
• Do not touch the glass tip of the chamber probe or the heater-plate during use or directly after
use as this may result in minor skin burns.
• Do not use the 900ST100 Adaptor if there is visible damage to the adaptor as this may
compromise system performance.
• Do not use the humidification chamber if the seal is not intact or the humidification chamber has
been dropped. Broken seal or cracks may result in water and gas leaks.
• Mount the humidifier so that the heater-plate is on a horizontal plane to prevent water spillage.
• Do not obstruct ventilation slots on the humidifier as this may cause overheating.
• Ensure the 900ST100 Adaptor connectors are dry at all times. Failure to do so may damage the
device.
• Operate the F&P HumiGard™ Surgical Humidification System within the recommended operating
conditions.
• Connect to output of a source delivering CO2.
• Do not exceed the maximum set flow rate.
• Do not modify the humidifier or accessories.
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6. Device Description
F&P HumiGard™ Surgical Humidifier
Finger-guard:
Prevents touching the
hot heater-plate and
keeps chamber in place
MR860AEU
Temperature display:
Indicates the humidification chamber
outlet temperature when the
temperature display button is pressed
Temperature display
button:
Displays the temperature
on the temperature
display when pressed
Heater-plate:
Heats water to supply
heat and humidity to
the insufflation gas
Standby/ON button:
Toggles the heater-base
between ON and
Standby mode
Operational indicators:
Indicates incorrect
connections, humidity
level and hardware
faults
Adaptor port:
Attaches the adaptor to
the humidifier
7. Accessory Description
7.1 900ST100 Adaptor
Heater-wire plug:
Provides electrical
connection from
the adaptor to the
humidified insufflation
tube heater wire
Chamber probe:
Measures the chamber
outlet temperature
and flow rate of gas
traveling through the
humidified insufflation
tube
Ambient sensor:
Measures ambient
temperature
Humidifier plug:
Provides electrical
connection between
the humidifier and the
adaptor
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7.2 Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
Luer lock:
Connects the humidified
insufflation tube to the
patient interface
Humidified insufflation
tube:
Delivers humidified warm
gas for insufflation
Filter tube:
Filters and delivers the
insufflation gas to the
humidification chamber
Elbow:
Connects the humidified
insufflation tube to the
humidification chamber
CO2
Funnel:
Assists with pouring
sterile water into
the humidification
chamber
Barb connector:
Connects the filter tube to
insufflators with barbed
gas outlets
Humidification chamber:
Holds water used to
humidify and warm the
insufflation gas
Heater-wire socket:
Provides electrical
connection from the
humidifier to the heaterwire in the humidified
insufflation tube
Chamber probe socket:
Connects the chamber
probe of the 900ST100
Adaptor to the humidified
insufflation tube
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7.3 Laparoscopic Procedures – RT350 Humidified Insufflation Kit
Luer lock:
Connects the humidified
insufflation tube to the
patient interface
Humidified insufflation
tube:
Delivers humidified warm
gas for insufflation
Filter tube:
Filters and delivers the
insufflation gas to the
humidification chamber
Elbow:
Connects the humidified
insufflation tube to the
humidification chamber
CO2
Barb connector:
Connects the filter tube to
insufflators with barbed
gas outlets
Humidification chamber:
Holds water used to
humidify and warm the
insufflation gas
Insufflator connector:
Connects the filter tube to
insufflators with 22 mm gas
outlets. May be removed
from filter tube if not
required for connection
Heater-wire socket:
Provides electrical
connection from the
humidifier to the heaterwire in the humidified
insufflation tube
Chamber probe socket:
Connects the chamber
probe of the 900ST100
Adaptor to the humidified
insufflation tube
Veress bypass: Bypasses
the humidification
chamber for creation of
pneumoperitoneum with
a Veress needle
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7.4 Open Procedures – ST300 Open Surgery Humidification Kit with VITA-diffuser™
Luer lock:
Connects the humidified
insufflation tube to the
VITA-diffuser™
Humidified insufflation
tube:
Delivers humidified warm
gas for insufflation
Filter tube:
Filters and delivers the
insufflation gas to the
humidification chamber
Elbow:
Connects the humidified
insufflation tube to the
humidification chamber
CO2
VITA-diffuser™:
Diffuses gas into the wound.
Refer to VITA-diffuser™
Instructions
for Use (REF VdBXYYYYMM)
or the CarbonVITA™
Instructions for Use
(REF CVBXYYYYMM)
Funnel:
Assists with pouring
sterile water into
the humidification
chamber.
Heater-wire socket:
Provides electrical
connection from the
humidifier to the heaterwire in the humidified
insufflation tube
Humidification chamber:
Holds water used to
humidify and warm the
insufflation gas
Chamber probe socket:
Connects the chamber
probe of the 900ST100
Adaptor to the humidified
insufflation tube
8. Initial Humidifier Set-up Instructions
1 Remove the humidifier from its packaging. Attach the appropriate power plug. Plug the power
cord into the power supply.
2 Ensure that the humidifier is level and securely mounted. A range of mounting solutions and
power plugs is available from Fisher & Paykel Healthcare. Please contact your Fisher & Paykel
Healthcare representative or distributor for assistance in selecting the most suitable mounting
bracket.
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9. Operating Instructions
9.1 Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
NOTE: Instructions specific for sterile theatre staff are shaded grey.
1 Chamber preparation
a Open the ST310 Laparoscopic Humidification Kit and remove the humidification chamber.
b Press down on the finger-guard and slide the humidification chamber onto the heater-plate.
The finger-guard will “click” when the chamber is in position.
c Remove the port caps from the humidification chamber.
2 Add sterile water to the humidification chamber ~180 mL. A funnel is included in the kit to
assist with the addition of water to the humidification chamber. Water should not exceed the
indicator line on the chamber.
3 Plug the humidifier plug of the adaptor into the adaptor port. Attach the filter end of the filter
tubing to the insufflator. There is a barb connector provided to allow connection to a barbed
insufflator outlet if required. Attach the other end of the filter tubing to the humidification
chamber.
4 Press the Standby/ON button to turn the humidifier “ON” and enter preheat mode. Preheat
mode allows the advance set up of non-sterile components and ensures that the optimal
temperature and humidity for procedures will be achieved as soon as gas flow commences.
During preheat mode:
• The ON indicator will flash continuously.
• The LED will display a stepped sequence and make an audible indication every five
minutes.
• The heater-wire plug operational indicator will flash, indicating that the device is still in preheat mode and requires complete connection of the 900ST100 Adaptor to enter standard
operation mode. If using preheat mode it is recommended that the device remain in preheat mode for at least 10 minutes prior to when gas flow is desired.
5 Connecting the humidified insufflation tube
a Using a sterile technique, remove the humidified insufflation tube from the sterile
packaging.
b Pass the elbow of the humidified insufflation tube to the non-sterile theatre staff for
connection to the 900ST100 Adaptor.
c Connect the chamber probe of the 900ST100 Adaptor to the chamber probe socket. For a
secure fit ensure that the “V”-shaped moulding on the chamber probe aligns securely with
the “V”-shaped cut-out on the humidified insufflation tube.
d Connect the heater-wire plug to the heater-wire socket on the humidified insufflation tube.
The humidifier will automatically switch from pre-heat to normal operation. Attach the
elbow of the humidified insufflation tube to the humidification chamber.
6
Turn the gas flow on and purge the system with at least 500 mL of CO2 gas.
Connect the luer lock of the humidified insufflation tube to the patient interface.
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1
2
3
STERILE
H2O
mmHg
L/min
∑L
~180 mL
4
5
6
500 mL CO2
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9.2 Laparoscopic Procedures – RT350 Humidified Insufflation kit
NOTE: Instructions specific for sterile theatre staff are shaded grey.
1 Chamber preparation
a Open the RT350 Humidified Insufflation Kit and remove the non-sterile portion. Open the
non-sterile portion and remove the humidification chamber.
b Press down on the finger-guard and slide the humidification chamber onto the heaterplate. The finger-guard will “click” when the chamber is in position.
c Remove the port caps from the humidification chamber.
2 Add sterile water to the humidification chamber ~30 mL. The water level in the chamber
should not exceed the indicator line. Monitor the water level throughout the procedure. The
water in the chamber is intended to last for up to 600 L of CO2; top up the water during the
procedure if required.
3 Attach the connector end of the filter tubing to the insufflator. The insufflator connector can
be removed for alternate connections to some insufflator outputs. There is a barb connector
in the kit to allow connection to a barbed insufflator outlet if required. For ease of connection
it is recommended to attach the filter tube on the opposite side to the adaptor port.
4 Connecting the humidified insufflation tube
a Using a sterile technique, remove the humidified insufflation tube from the sterile
packaging.
b Pass the elbow of the humidified insufflation tube to the non-sterile theatre staff for
connection to the 900ST100 Adaptor.
c Connect the chamber probe of the 900ST100 Adaptor to the chamber probe socket. For
a secure fit ensure that the “V”-shaped moulding on the chamber probe aligns securely
with the “V”-shaped cut-out on the humidified insufflation tube.
d Connect the heater-wire plug to the heater-wire socket.
WARNING: If a Veress needle is used to create pneumoperitoneum the chamber must be
bypassed during initial insufflation to prevent pressure fluctuations on the insufflator. If a
Veress needle is not used, proceed to Step 6 below .
5 Veress bypass
a Attach the Veress bypass at the elbow of the humidified insufflation tube and connect to
the filter of the filter tube.
b Connect the luer lock to the Veress needle; purge the system with at least 200 mL of CO2
before creating pneumoperitoneum.
c Once pneumoperitoneum is created and the Veress needle is removed, remove the
Veress bypass.
6 Completing connection of the humidified insufflation tube
a Attach the elbow of the humidified insufflation tube to the humidification chamber.
b Attach the humidifier plug of the adaptor to the adaptor port.
7 Turn the gas flow on and purge the system with at least 500 mL of CO2 gas.
8 Connect the luer lock of the humidified insufflation tube to the patient interface.
9 Turn the humidifier “ON” by pressing the Standby/ON button.
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1
3
2
STERILE
mmHg
L/min
∑L
~30 mL
5
4
200 mL
CO2
6
8
7
CO2
500 mL CO2
9
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9.3 Open Procedures – ST300 Open Surgery Humidification Kit with VITA-diffuser™
NOTE: Instructions specific for theatre staff are shaded grey.
1 Chamber preparation
a Open the ST300 Open Surgery Humidification kit and remove the humidification
chamber.
b Press down on the finger-guard and slide the humidification chamber onto the heaterplate. The finger-guard will “click” when the humidification chamber is in position.
c Remove the port caps from the humidification chamber.
2 Add sterile water to the humidification chamber. A funnel is included in the kit to assist with
the addition of water to the humidification chamber. Water should not exceed the indicator
line on the chamber.
3 Attach the filter tubing to the CO2 gas source. Attach the filter end of the filter tubing to the
humidification chamber. For ease of connection it is recommended to attach the filter tube
on the opposite side to the adaptor port.
4 Plug the humidifier plug into the adaptor port. Press the Standby/ON button to turn
the humidifier “ON” to enter preheat mode. Preheat mode will heat the water in the
humidification chamber so that the optimal temperature and humidity for procedures will be
achieved as soon as gas flow commences.
During preheat mode:
• The ON indicator will flash continuously.
• The LCD will display a stepped sequence and make an audible indication every five
minutes.
• The heater-wire plug operational indicator will flash, indicating that the device is still
in preheat mode and requires complete connection of the 900ST100 Adaptor to enter
standard operation mode.
For optimal temperature and humidity delivery it is recommended that the device
remains in preheat mode for at least 10 minutes prior to when gas flow is desired.
5 Connecting the humidified insufflation tube
a Using a sterile technique, remove the humidified insufflation tubing from the sterile
packaging.
b Pass the elbow of the heated humidified insufflation tubing to the non-sterile theatre
staff for connection to the 900ST100 Adaptor.
c Connect the chamber probe of the 900ST100 Adaptor to the chamber probe socket. For
a secure fit ensure that the “V”-shaped moulding on the chamber probe aligns securely
with the “V”-shaped cut-out on the humidified insufflation tube.
d Connect the heater-wire plug to the heater-wire socket on the humidified insufflation
tube. The humidifier will automatically switch from preheat to normal operation. Attach
the elbow of the humidified insufflation tube to the humidification chamber.
6 Connect the luer lock of the humidified insufflation tube to a VITA-diffuser™.
Use the system with 10 L/min CO2 gas.
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1
2
STERILE
3
H2O
~180 mL
CO2
4
5
6
10 L/min CO2
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10. Front Panel Indicators and Troubleshooting
Water indicator:
Lights to remind user
to check the chamber
water level
Heater-wire Plug and
Chamber Probe Indicator:
Lights up when in preheat
mode, if the 900ST100
Adaptor is not inserted into
the humidified insufflation
tube, when the humidification
chamber temperature is being
displayed or if the 900ST100
Adaptor is faulty
ON indicator:
Solid light indicates that the
humidifier is on. Flashing light
indicates that the humidifier is
in preheat mode
Adaptor indicator:
Lights if the 900ST100 Adaptor
is not correctly plugged into the
humidifier or if the 900ST100
Adaptor is faulty
Hardware fault indicator:
The humidifier requires
servicing. Humidification will
not be delivered when this
indicator is illuminated.
For servicing refer to the
MR860 Humidifier Technical
Manual (REF 185046474)
Temperature display:
Indicates the humidification
chamber outlet temperature
when the temperature display
button is pressed
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11. General Cleaning Instructions
Surgical Humidifier:
1
2
3
Disconnect the humidifier from any electrical outlet.
Using a damp cloth, clean the humidifier with one of the following solutions:
• Isopropyl alcohol
• Dishwashing detergent.
Wipe the humidifier clean of any cleaning residues before use.
WARNING: To avoid electric shock do not immerse the humidifier into any liquid.
900ST100 Adaptor:
1 If visible matter is seen on the 900ST100 Adaptor, wipe clean with an alcohol swab.
2 If disinfection is desired, follow the instructions for disinfection in the 900ST100 User Instructions
(REF 185046318). Do not immerse the adaptor’s electrical connections into any liquid.
To prevent damage to the adaptor:
• Do not autoclave.
• Keep electrical connections dry.
• Follow the cleaning agent manufacturer’s instructions carefully.
For detailed instructions on routine cleaning consult the MR860 Humidifier Technical Manual
(REF 185046474) or 900ST100 User Instructions (REF 185046318).
12. Routine Maintenance, Servicing and Calibration
In order to keep your humidifier in good working order, it is necessary for qualified service personnel
to perform maintenance at regular intervals. A full technical description including maintenance and
service data is contained in the MR860 Humidifier Technical Manual (REF 185046474) available from
your Fisher & Paykel Healthcare office or distributor.
DEVICE
REGULAR
MAINTENANCE PERIOD
MAINTENANCE ASPECTS
Refer to Humidifier Technical Manual for
detailed instructions (REF 185046474)
MR860 Humidifier
12 months
• Check for damage
• Carry out a performance test
900ST100 Adaptor
6 months
• Check for damage
• Check accuracy
• Cleaning
13. Device and Accessory Disposal Instructions
13.1 Humidifier and Adaptor Disposal Instructions
The MR860 Humidifier and 900ST100 Adaptor are intended for repeat use. If disposal is
required please do not discard as regular rubbish. Dispose of electronics according to local
guidelines.
13.2 Accessory Disposal Instructions
The components of the ST310 Laparoscopic Humidification Kit, RT350 Humidified
Insufflation Kit and the ST300 Open-surgery Humidification Kit are single use.
After each procedure discard all of the components of the kit according to theatre protocol.
It is recommended to incinerate consumables after use.
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14. Specifications
14.1 F&P HumiGard™ Surgical Humidifier
Dimensions (without chamber fitted): 140 mm x 173 mm x 135 mm
Mass (without chamber fitted): 2.8 kg
Supply voltage: 230 V ~
Supply frequency: 50 Hz
Supply current: 1 A @ 230 V ~
Rated Input: 230 W
Heater-plate: 150 W
Heater-wire: 22 V ~, 60 W MAX
93/42/EEC Class IIa Medical Device
Recommended operating environment: 18 °C to 24 °C
IP rating: IPX1
Humidity performance (0 to 10 L/min): > 33 mg/L
Humidity (Min): 20% RH
Humidity (Max): 60% RH
If you are considering operating the system outside the recommended temperature range first consult your local
Fisher & Paykel Healthcare office or distributor. Refer to product technical manual (REF 185046474) for electromagnetic compatibility information. NOTE: This device is latex free.
DISPLAY
Three-digit 14 mm 7-segment LED
Display range:
Display accuracy: (25 °C to 45 °C )
10 °C to 70 °C
+/- 2 °C
14.2 Laparoscopic Procedures – ST310 Laparoscopic Humidification Kit
Maximum gas pressure:
30 mmHg
Input set flow rate:
≤ 45 L/min
Maximum achieved flow rate:
15 L/min
Resistance to flow: @ 1 L/min
0.6 mmHg
@ 2 L/min
1.4 mmHg
@ 5 L/min
4.4 mmHg
Leakage (@ 30 mmHg):
< 50 mL/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~180 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
14.3 Laparoscopic Procedures – RT350 Humidification Kit
Maximum gas pressure:
30 mmHg
Input set flow rate:
≤ 45 L/min
Maximum achieveable flow rate:
15 L/min
Resistance to flow: @ 1 L/min
0.5 mmHg
@ 2 L/min
1.2 mmHg
@ 5 L/min
3.9 mmHg
Leakage (@ 30 mmHg):
< 50 mL/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~30 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
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al
ro-
14.4 Open Procedures – ST300 Open Surgery Humidification Kit
Maximum achieved flow rate:
≤ 15 L/min
Maximum Input set flow rate:
≤ 15 L/min
Recommended flow rate
10 L/min
Warm-up time:
≤ 10 mins
Humidification chamber reservoir
~180 mL (Use sterile water)
Luer fittings conform to ISO 594-1:1986 and ISO 594-2:1998
15. Symbol Definitions
Do not use if package is
damaged
C-Tick for EMC
Use sterile water
Caution - Hot Surface
STANDBY/ON Button
Use only carbon
dioxide gas
Resistant to vertical
falling drips
Peel the sterile bag
open in direction
indicated
Do not use oxygen gas
Fragile.
Handle With Care
Excess water in the
chamber
Prior to gas flow,
Preheat mode will
heat the water
This Way Up
Correct water level in
the chamber
16. Approved Accessories
Using non-approved accessories or spare parts could be unsafe.
Use only the following approved products from your Fisher & Paykel Healthcare supplier:
General Accessories
900ST100 Adaptor
Laparoscopic Accessories
ST310 Laparoscopic Humidification Kit
RT350 Humidified Insufflation Kit
Open Surgery Accessories
ST300 Open Insufflation Kit
VITA-diffuser™ manufactured by Cardia Innovation AB
CarbonVITA™ manufactured by Cardia Innovation AB
VITA-diffuser™ and CarbonVITA™ are registered trademarks of Cardia Innovation AB
NOTE: Accessories may not be available in all countries. Contact your local Fisher & Paykel Healthcare
office or distributor for more information.
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目录
1
开始之前
B2
2
设计用途
B2
3
操作人员要求
B2
4
警告
B2
4.1
一般警告
B2
4.2
腹腔镜手术时警告
B2
4.2.1 仅适用于 ST310 腹腔镜手术用湿化套装
B2
4.2.2 仅适用于 RT350 湿化充气套装
B2
4.3
开放性手术时警告
B3
5
一般注意事项
B3
6
湿化器介绍
B4
7
附件介绍
B4
7.1
900ST100 连接线
B4
7.2
腹腔镜手术-ST310 腹腔镜手术用湿化套装
B5
7.3
腹腔镜手术-RT350 湿化充气套装
B6
7.4
开放性手术-带 VITA-diffuser™ 的 ST300 开放性手术用湿化套装
8
湿化器首次安装说明
9
B7
B7
操作说明
B8
9.1
腹腔镜手术 - ST310 腹腔镜手术用湿化套装
B8
9.2
腹腔镜手术-RT350 湿化充气套装
B10
9.3
开放性手术 - 带 VITA-diffuser™ 扩散器的 ST300 开放性手术用湿化套装
B12
10
前面板指示灯和故障排除
B14
11
一般清洁说明
B15
12
常规维修、保养和校准
B15
13
湿化器和附件终末处理说明
B15
13.1
湿化器和连接线终末处理说明
B15
13.2
附件终末处理说明
B15
14
规格
B16
14.1
费雪派克 F&P HumiGard™ 手术用湿化器
B16
14.2
腹腔镜手术-ST310 腹腔镜手术用湿化套装
B16
14.3
腹腔镜手术-RT350 湿化套装
B16
14.4
开放性手术-ST300 开放性手术用湿化套装
B17
15
符号含义
B17
16
认可的附件
B17
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使用说明
MR860AEU
zh
1. 开始之前
使用前请仔细阅读本手册,并妥善保留这些说明以备将来参考。如湿化器任何附件无法正常工
作,请联系费雪派克医疗保健公司 (Fisher & Paykel Healthcare) 在您当地的办事处(详见封底)
或合适的经销商。
2. 设计用途
用于对术中充气用气体进行加温湿化。
腹腔镜手术
适用于在腹腔镜手术过程中用二氧化碳 (CO2) 充气的各种年龄段的患者。
开放性手术
适用于在开腹或开胸手术过程中用二氧化碳 (CO2) 充气的各种年龄段的患者。
3. 操作人员要求
由具有手术设备安装(包括无菌器械操作)经验的医护人员操作。使用前,使用者必须阅读使用
手册和相关附件的使用手册。
4. 警告
4.1 一般警告
• ST310 腹腔镜手术用湿化套装、RT350 湿化充气套装和 ST300 开放性手术用湿化套装仅供一
次性使用。重复使用可能会造成传染性物质传播、干扰治疗、严重损伤或死亡。使用后请将耗
材焚毁。
• 为确保湿化送气管的无菌性,使用前请仔细检查无菌包装是否损坏。如有损坏请丢弃。
• 为避免触电,此设备必须连接到带有接地保护的电源。
为避免输出气体中含有过剩的能量,请勿:
• 使用经过预先加温的二氧化碳 (CO2) 气体。
• 向湿化水罐加入温度超过 37 °C 的水。
• 用手术巾盖住湿化送气管。
• 将湿化送气管盘绕。
• 请勿使用除二氧化碳 (CO2) 以外的其他气体。
4.2 腹腔镜手术时警告
• 为防止气体栓塞,充气前请先用 (CO2) 将系统中的气体排清。
• 为确保使用的安全性和有效性,请不要超过充气机的最大设定流量 (≤ 45 升/分钟)。
• 为避免充气机上压力读数不正确,请确保所使用的充气机按生产厂商的指导定期维护和/或准。
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4.2.1 仅适用于 ST310 腹腔镜手术用湿化套装
• 当使用气腹针时,为保证充气机上的压力读数稳定和精确,请确定湿化水罐中已加水至约
180 毫升的推荐水位。
4.2.2 仅适用于 RT350 湿化充气套装
• 当使用气腹针时,为保证吹气机上的压力读数稳定和精确,请使用气腹针旁通接头。
• 为防止 Conmed-Linvatec GS1002 充气机出现任何压力波动,使用气腹针时,请先用传统的
送气管形成人工气腹。
4.3 开放性手术时警告
• 为确保为手术部位有效地充分放气,请仅与经过认可的气体扩散器配套使用。Cardia Innovation
AB 公司制造的 VITA-diffuser™ 扩散器已得到认可可与 ST300 开放性手术用湿化套装配套使用。
• 有关 VITA-diffuser™ 扩散器的正确使用方法,请参考 VITA-diffuser™ 使用说明
(REF VdBXYYYYMM) 或 CarbonVITA™ 使用说明 (CVBXYYYYMM)。
• 为确保使用的安全性和有效性,请不要超过最大流量 (≤ 15 升/分)。
5. 一般注意事项
为确保患者安全及达到最佳疗效和设备性能:
• 请仅使用费雪派克医疗保健公司 (Fisher & Paykel Healthcare) 认可的附件。
• 湿化器正用于患者时,请勿使用串行端口,因为这可能会导致与其他设备之间产生电磁干扰。
• 维护前,请务必断开电源。未断开电源会降低用电安全性。
• 请勿在使用期间或使用后立即触摸水罐端探头上的玻璃尖端或加热板,因为这可能导致皮肤轻
微灼伤。
• 如果 900ST100 连接线有可见破损,请勿使用。因为这可能会降低系统性能。
• 如果湿化水罐密封不严或曾跌落,请勿使用。密封破损或裂痕可能会导致漏水或漏气。
• 固定湿化器,让加热盘处于水平位以防止水溢出。
• 请勿阻塞湿化器上的散热槽口,因为这可能会导致过热。
• 请确保 900ST100 连接线接头始终保持干燥。否则可能会损坏湿化器。
• 请在建议的运行条件下使用费雪派克 F&P HumiGard™ 手术用湿化系统。
• 请连接到二氧化碳 CO2 气源的输出口。
• 请不要超过最大设定流量。
• 请不要改装湿化器或附件。
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6. 湿化器介绍
费雪派克 F&P HumiGard™ 手术用湿化器
护手板:
防止触摸到灼热的加
热盘,同时固定湿
化水罐
MR860AEU
温度显示屏:
按下温度显示按钮时显示湿化水罐出
口端气体温度
温度显示按钮:
按下时在温度显示屏上
显示温度
加热盘:
加热水,为充入的气
体提供热量和湿度
待机/开机按钮:
使加热底座在开机和
待机模式间转换
工作指示灯:
指示错误连接、湿度
水平和硬件故障
连接线端口:
将连接线连接到湿
化器
7. 附件介绍
7.1 900ST100 连接线
加热丝插头:
提供从连接线到湿化
送气管加热丝的电
气连接
水罐端探头:
测量通过湿化送气管
的气体在水罐出口处
的温度和流量
环境传感器:
测量环境温度
湿化器插头:
提供湿化器和连接线之
间的 电气连接
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7.2 腹腔镜手术-ST310 腹腔镜手术用湿化套装
luer 鲁尔接头:
连接湿化送气管和病
人界面
湿化送气管:
输送经过加温加湿的气
体以充气
过滤管:
过滤并输送充气用气体
至湿化水罐
弯头:
连接湿化送气管和湿
化水罐
CO2
漏斗:
辅助将无菌水加入
湿化水罐
沟槽式接头:
连接过滤管和带沟槽式
气源出口的充气机
湿化水罐:
贮水以用来为充气气体
加温加湿
加热丝插槽:
提供从湿化器到湿化
送气管内加热丝的电
气连接
水罐端探头插槽:
将 900ST100 连接线的
水罐端探头连接到湿化
送气管
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