Manual
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Sophie Neonatology Ventilator
Cleaning & Disinfection Instructions
®
11.1
1
Care and Maintenance
1.1
Disinfection and sterilization
Disinfection and sterilization
The device must only be cleaned and disinfected (and operated) by instructed staff. Caution
Routine cleaning must be carried out according to local hospital routine in regular periods. All disposable parts must be disposed of in an environment friendly manner according to the local hospital routine. Decontamination methods
Rinsing in water Rinsing in 70% alcohol solution Wiping with a cloth moistened with disinfectant.
Disinfection methods
Boiling Dipping into disinfectant. Washing in a medical dishwasher All instrument and surface disinfectants with alcohol and aldehyde as effective agents can be used. Disinfectants containing oxygen or chlorine releasing substances or phenols and its derivates are not suitable. Amino derivates can damage soft plastics (hoses).
All used disinfectants must have been approved according to the respective environment laws. Caution
© F. Stephan GmbH
GA-038-0608V1.2-HAO-en
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Care and Maintenance
The regulations issued by the professional association for handling cleaning agents and disinfectants must be observed. Caution
When using cleaning agents and disinfectants, pay attention to the correct concentration and working time to rule out any damage to the materials. Caution
When using agents other than those specified, please contact the manufactures of the disinfectant to have the compatibility confirmed. Caution
Caution
Sterilization methods
Ask the manufacturer of the disinfectant you are using to provide information about compatibility of the substances when used for ventilation and inhalation systems (safety data sheet, toxicity).
Autoclaving with steam Plasma sterilization
1.1.1
Housing, gas supply hoses, electric cables Cleaning Method
Wiping disinfection 1. Wipe surfaces with disinfection solution ready for use (surface disinfectant). 2. The cloth should only be moist. 3. No Humididity must penetrate into the device.
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1.1
1.1.2
Disinfection and sterilization
Patient hose system Cleaning
Disinfection Sterilization Preference should be given if possible to thermal treatment in a machine
Preparation
1. Remove the pneumotachograph from the Y piece. 2. Remove the Y piece from the inspiration and expiration hose 3. Remove inspiration and expiration hose from the respective connections at the front of the patient component. Always hold the patient hoses at the coupling and not by the support coil.
Caution
4. Remove the pressure measuring adapter from the expiration tube. 5. Remove the temperature sensors from the inspiration tube. 6. Remove all tubes and cables of the patient tube system from the connections on the right of SOPHIE. Disinfection method
Preference should be given to a pH-neutral cleaning agent. Please only use citric acid to neutralize alkaline cleaning agents. Wiping disinfection
Temperature sensors may only be disinfected by wiping. Wipe temperature sensors with a disinfection solution ready for use. The cloth should only be moist.
© F. Stephan GmbH
GA-038-0608V1.2-HAO-en
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Care and Maintenance
Boiling
Application: A. Suitable for killing vegetative bacteria including mycobacteria, fungi and fungi spores B. Suitable for inactivating viruses C. Suitable for killing spores of the anthrax pathogen Exposure time: at least 3 minutes
application AB
at least 15 minutes
application ABC
Dipping in disinfectant.
Place all parts in the disinfection solution ready for use (instrument disinfectant); all parts must be covered completely with disinfectant and there must not be any air bubbles in the hoses. Rinse the disinfectant off completely after the exposure time with cold water of at least drinking water quality. Dry the disinfected parts (possibly in a drying cupboard). Medical dishwasher
Fill the automatic disinfecting machine according to the manufacturer's operating instructions and start the program for anesthesia material. Dry the disinfected parts (possibly in a drying cupboard) if this is not carried out in the automatic disinfection machine. Sterilization method
Autoclaving
All parts can be autoclaved with steam up to 140 °C. Fill the autoclave according to the manufacturer's operating instructions and start the corresponding program.
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1.1
1.1.3
Disinfection and sterilization
Patient component Disinfection
Cleaning
Sterilization Preference should be given if possible to thermal treatment in a machine.
1.1.3.1 Preparing the patient component
Fig. 88: Preparing the patient component
© F. Stephan GmbH
1
Locking lever
5
Humidifier tube
2
Patient valve
6
Humidifier tube locking ring
3
Installation wrench
7
Silencer
4
Humidifier bottle
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Care and Maintenance
1. Adjust the locking lever to "OPEN". The patient component can now be removed from the side wall. 2. Unscrew and drain humidifier bottle. 3. Pull off the humidifier tube downwards. 4. Turn the locking ring clockwise to remove the humidifier tube. 5. Remove the humidifier fleece and dispose of correctly. 6. Unscrew the patient valve using the supplied installation wrench.
1.1.3.2
Preparing to lubricate the patient valve
Fig. 89: Preparing the patient valve 1. There must not be any deposits on the black valve piston which could prevent the piston from moving in the double valve housing. If there are impurities and deposits on the patient valve, clean it in an ultrasonic bath. 2. After this checking and before disinfecting or sterilizing, check the O-rings of the patient valve for any signs of damage. Lubricate them lightly with oxygen grease. Damaged O-rings must be replaced.
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1.1
Disinfection and sterilization
Fig. 90: Oxygen grease 3. Grease the O-rings lightly by applying a little oxygen grease to disposable gloves.
Fig. 91: Grease the O-rings 4. Make sure that no grease can get into the bores of the double valve housing; grease must really only be applied to the O-rings. Never apply grease to the piston. The O-rings shimmer slightly after greasing. 5. The patient valve can be screwed back into the patient component as far as it will go, using the installation wrench.
© F. Stephan GmbH
GA-038-0608V1.2-HAO-en
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Care and Maintenance
1.1.3.3 Preparing to replace the humidifier fleece
Fig. 92: Insert humidifier fleece 1
Inner tube
4
Inserting tool
2
Outer tube
5
Locking ring
3
Humidifier fleece
6. Place the humidifier fleece over the inserting tool, without covering the cut-out with fleece. 7. Insert between outer and inner tube. 8. The fleece must be positioned in such a way that it certainly can no longer be seen in the cut-out of the outer tube. 9. Push the locking ring in and tighten counterclockwise. 10. Make sure that the fleece cannot be seen in the cut-out of the outer tube. For instance, it can help to put your thumb in the cut out. 11. Place the complete humidifier tube onto the holding bush at the bottom of the patient component.
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1.1
1.1.3.4
Disinfection and sterilization
Method
Disinfection method
Preference should be given to a pH-neutral cleaning agent. Please only use citric acid to neutralize alkaline cleaning agents. Boiling
Application: A. Suitable for killing vegetative bacteria including mycobacteria, fungi and fungi spores B. Suitable for inactivating viruses C. Suitable for killing spores of the anthrax pathogen Exposure time: at least 3 minutes
application AB
at least 15 minutes
application ABC
Dipping in disinfectant.
Place all parts in the disinfection solution ready for use (instrument disinfectant); all parts must be covered completely with disinfectant and there must not be any air bubbles in the hoses. Rinse the disinfectant off completely after the exposure time with cold water of at least drinking water quality. Dry the disinfected parts (possibly in a drying cupboard).
Medical dishwasher
Fill the automatic disinfecting machine according to the manufacturer's operating instructions and start the program for anesthesia material. Dry the disinfected parts (possibly in a drying cupboard) if this is not carried out in the automatic disinfection machine.
Sterilization method
Autoclaving
All parts can be autoclaved with steam up to 140 °C. Fill the autoclave according to the manufacturer's operating instructions and start the corresponding program.
© F. Stephan GmbH
GA-038-0608V1.2-HAO-en
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Care and Maintenance
1.1.4
Pneumotachograph Disinfection
Cleaning
Sterilization
Make sure that the inner tubes including the webs of the PTN are not damaged during cleaning and sterilization. Caution
Rinse the PNT carefully under running water before disinfection or sterilization to ensure that no more secretion residues or other impurities are still present. Also clean the pressure measurement hoses under running water if there are visible impurities. Preperation
7 5 6 3
1
2
4
Fig. 93: Preparing the PNT 1
Pressure measurement hoses
5
Vortex body
2
Connector 1
6
Hook
3
Connector 2
7
Assembly tool
4
Pneumotachograph
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© F. Stephan GmbH
®
1.1
Disinfection and sterilization
1. Pull the pressure measurement hoses off the PNT connectors. 2. Carefully pull the vortex body out on both sides of the PNT. 3. To do so, insert the hook of the assembly tool into two opposite bores of the vortex bodies so that the vortex bodies can be pulled out easily without damaging the bores. Disinfection method
Preference should be given to a pH-neutral cleaning agent. Please only use citric acid to neutralize alkaline cleaning agents. Boiling
Application: A. Suitable for killing vegetative bacteria including mycobacteria, fungi and fungi spores B. Suitable for inactivating viruses C. Suitable for killing spores of the anthrax pathogen Exposure time: at least 3 minutes
application AB
at least 15 minutes
application ABC
Dipping in disinfectant.
Place all parts in the disinfection solution ready for use (instrument disinfectant); all parts must be covered completely with disinfectant and there must not be any air bubbles in the hoses. Rinse the disinfectant off completely after the exposure time with cold water of at least drinking water quality. Dry the disinfected parts (possibly in a drying cupboard). Sterilization method
Autoclaving
All parts can be autoclaved with steam up to 140 °C. Fill the autoclave according to the manufacturer's operating instructions and start the corresponding program for anesthesia material.
© F. Stephan GmbH
GA-038-0608V1.2-HAO-en
1
Care and Maintenance
After treatment 4 8 a
5
b 4
7
Fig. 94: PNT after treatment 4
PNT-housing
5
Vortex body
a
Zero ring of the vortex body
7
Assembly tool
b
Flat end of the assembly tool
8
Concentric tube system
1. Check that all parts are mechanically undamaged and complete. 2 vortex bodies with one zero ring each PNT housing with concentric tube system, held by three webs each. Check that the tube system fits firmly in the housing. 2 connectors 2. Carefully blow the parts out with compressed air so that there is no water in the connectors. 3. Pick up the vortex bodies with the flat end of the assembly tool and insert them into the PNT-housing. 4. Push the vortex bodies up as far as they will go and check that they fit firmly. 5. Connect the pressure measurement hoses to the connectors.
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®
1.1
Disinfection and sterilization
6. Connect the red pressure measurement hose (proximal pressure measurement hose) onto connector 1 near the attachment fitting (wide opening) of the PNT (marked by a black point on the plug and PNT housing). 7. Connect the second pressure measurement hose onto connector 2.
Danger
1.1.5
The pneumotachograph type B and type C have different vortex bodies with different bore diameters (type B: 5.2 mm, type C: 6.4 mm). They must not be confused, otherwise significant measuring errors must be expected.
Assembly Storage
Store dry and protected from dust until next time the device is used.
Preparing for operation
Details on preparing for operation can be found in chapter 4.2.2 from page 59.
Function test
Hazard procedures
© F. Stephan GmbH
Before starting SOPHIE, always carry out a test (see chapter 7 from page 107). If you find any damage on the device or accessories during or after preparation, please contact your medical technology department or the authorized Customer Service of F. STEPHAN GMBH
GA-038-0608V1.2-HAO-en
GA-038-0608V1.2-HAO-en ☺☺
☺☺
☺☺
☺☺
☺☺
QAV
☺☺
?
?
?
?
?
?
derivate
Amino
Tab. 15: Disinfection and sterilization table
© F. Stephan GmbH
conditionally suitable
not suitable
?
No data exist
suitable
☺☺
?
?
?
?
releasing
O2/Cl
☺
☺☺
Biguanide
without humidifier fleece
70 %
Alcohol
☺☺
☺☺
☺☺
Aldehyde
Please observe user instructions. Please note that the individual parts will be placed into a close-meshed small parts sieve in the disinfection machine to prevent damage to the vortex bodies.
c acid
manual
!!!
Device housing
Hose system
☺☺
☺☺
☺☺☺
PNT hose
☺☺☺
☺!!!
☺☺☺
PNT head
Temperature sensor
☺☺
☺☺☺
Humidifier bottle
acid
☺☺
with humidifier
STERAD
140°C
☺☺☺
Patient component
H2O2
up to
Phosphori
Thermal treatment in a machine
Steriliz ation
Autocla ve
derivates
Phenol &
1.2
Citric
Disinfection
Sterilization
1 Care and Maintenance
Desinfektions- und Sterilisationsübersicht