MR860AEU HumiGard Instructions for Use Rev C Dec 2011

Page 1

SURGICAL HUMIDIFICATION SYSTEM

MR860AEU

Surgical Humidification System Instructions for Use

d

d,

MR860-185046315C_CD_FA.indd 3

1/20/12 9:38 AM

Page 2

Section

en

English

A1

(Chinese Simplified)

zh

B1

cs

Czech

C1

dn

Dansk

D1

de

Deutsch

E1

es

Español

F1

fr

Français

G1

el

Greek

H1

it

Italiano

I1

(Korean)

ko

J1

nl

Nederlands

K1

no

Norsk

L1

pl

Polish

M1

pt

Português

N1

fi

Suomi

O1

sv

Svenska

P1

(Chinese Traditional)

zht

tr

Turkish

MR860-185046315C_CD_FA.indd 4

Q1

R1

1/20/12 9:38 AM

Page 4

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.

MR860 | A2

MR860-185046315C_CD_FA.indd 2

1/20/12 9:38 AM

Page 5

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.

MR860 | A3

MR860-185046315C_CD_FA.indd 3

1/20/12 9:38 AM

Page 6

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

MR860 | A4

MR860-185046315C_CD_FA.indd 4

1/20/12 9:38 AM

Page 7

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

MR860 | A5

MR860-185046315C_CD_FA.indd 5

1/20/12 9:38 AM

Page 8

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

MR860 | A6

MR860-185046315C_CD_FA.indd 6

1/20/12 9:38 AM

Page 9

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.

MR860 | A7

MR860-185046315C_CD_FA.indd 7

1/20/12 9:38 AM

Page 10

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.

MR860 | A8

MR860-185046315C_CD_FA.indd 8

1/20/12 9:38 AM

Page 11

1

2

3

STERILE

H2O

mmHg

L/min

∑L

~180 mL

4

5

6

500 mL CO2

MR860 | A9

MR860-185046315C_CD_FA.indd 9

1/20/12 9:38 AM

Page 12

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.

MR860 | A10

MR860-185046315C_CD_FA.indd 10

1/20/12 9:38 AM

Page 13

1

3

2

STERILE

mmHg

L/min

∑L

~30 mL

5

4

200 mL

CO2

6

8

7

CO2

500 mL CO2

9

MR860 | A11

MR860-185046315C_CD_FA.indd 11

1/20/12 9:38 AM

Page 14

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.

MR860 | A12

MR860-185046315C_CD_FA.indd 12

1/20/12 9:38 AM

Page 15

1

2

STERILE

3

H2O

~180 mL

CO2

4

5

6

10 L/min CO2

MR860 | A13

MR860-185046315C_CD_FA.indd 13

1/20/12 9:38 AM

Page 16

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

MR860 | A14

MR860-185046315C_CD_FA.indd 14

1/20/12 9:38 AM

Page 17

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.

MR860 | A15

MR860-185046315C_CD_FA.indd 15

1/20/12 9:38 AM

Page 18

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

MR860 | A16

MR860-185046315C_CD_FA.indd 16

1/20/12 9:38 AM

Page 19

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.

MR860 | A17

MR860-185046315C_CD_FA.indd 17

1/20/12 9:38 AM

Page 20

MR860 | A18

MR860-185046315C_CD_FA.indd 18

1/20/12 9:38 AM

Page 21

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

MR860 | B1

MR860-185046315C_CD_FA.indd 1

1/20/12 9:38 AM

Page 22

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。

MR860 | B2

MR860-185046315C_CD_FA.indd 2

1/20/12 9:38 AM

Page 23

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。

MR860 | B3

MR860-185046315C_CD_FA.indd 3

1/20/12 9:38 AM

Page 24

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

MR860 | B4

MR860-185046315C_CD_FA.indd 4

1/20/12 9:38 AM

Page 25

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

MR860 | B5

MR860-185046315C_CD_FA.indd 5

1/20/12 9:38 AM