Users Manual
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User's Manual VENTILATION SERVO-i/s CLEANING AND MAINTENANCE
| TABLE OF CONTENTS |
TABLE OF CONTENTS
1 Introduction 2 Routine cleaning 3 Maintenance
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| TABLE OF CONTENTS |
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1 INTRODUCTION TABLE OF CONTENTS
1.1 1.2 1.3 1.4 1.5
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Introduction Warnings, Cautions, and Important Symbols General information Wall diagrams
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1.1 INTRODUCTION Unless otherwise stated, the information in this User´s Manual is valid for all SERVO-i/s Ventilator Systems. Here you will find the information needed to clean and maintain the SERVO-i/s systems safely. The manual is divided into three sections: Introduction (mandatory information) Routine cleaning Maintenance Instructions relevant only for either SERVO-i or SERVO-s are marked. Parts included in SERVO-i only: Battery module Y sensor CO2 sensor Edi module
1.2 WARNINGS, CAUTIONS, AND IMPORTANT WARNING! Indicates critical information about a potential serious outcome to the patient or the user.
IMPORTANT: Indicates information intended to help you operate the equipment or its connected devices easily and conveniently.
1.3 SYMBOLS Hazardous waste The device contains parts which must not be disposed of with ordinary waste.
1.4 GENERAL INFORMATION As cleaning practices vary widely among health care institutions, it is not possible for MAQUET to specify particular practices that will meet all needs, or to be responsible for the effectiveness of cleaning procedures carried out in the patient care setting. MAQUET recommends methods that have been validated using the specified equipment and procedures outlined in this manual. Other methods may work but are not covered by the warranty unless MAQUET has given written permission.
Caution: Indicates instructions that must be followed in order to ensure the proper operation of the equipment.
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Cautions: All personnel should be aware of the risk of parts being infected when disassembling and cleaning the ventilator. All disposable parts must be discarded according to hospital routines and in an environmentally safe way.
1.5 WALL DIAGRAMS The wall diagrams are provided as checklists and contain overviews and step-by-step instructions for cleaning, to be posted on a wall.
IMPORTANT: Follow your hospital‘s guidelines for handling infectious material when handling any part of the SERVO-i/s ventilator system. If possible, cleaning should be performed immediately after use and always before disinfection/sterilization. Blood or other residues should not be allowed to dry onto the devices. Water quality affects cleaning/disinfection. MAQUET recommends drinking quality water as the minimum quality level. MAQUET recommends the use of Servo Duo Guard bacterial filter or equivalent to reduce the transmission of bacteria from the patient via the expiratory channel to the expiratory cassette. This reduces the risk of infection spread and prolongs the life of the expiratory cassette due to reduced cleaning requirements. The use of a washer-disinfector for cleaning/disinfection is recommended if bacterial filters are not used. Sterilization is normally not necessary for the expiratory cassette, as it is not an invasive instrument, but when applied, use validated processes only.
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2 ROUTINE CLEANING TABLE OF CONTENTS
2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9
Cleaning/disinfection procedures - a summary Preparations and dismantling Wiping and discarding Disinfection procedures Sterilization procedures (not recommended) Assembling SERVO Ultra Nebulizer cleaning SERVO-i NAVA system cleaning SERVO CO2 analyzer cleaning
2.10 Accessories
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2.1 CLEANING/DISINFECTION PROCEDURES - A SUMMARY
Disinfection when no bacterial filter is used Dismantle
A summary of the procedures for cleaning, disinfection and sterilization is given here. Details for each step are given in the following sections. Cleaning when bacterial filter is used Dismantle
Wipe off/discard
Rinse D1
D2
WasherDisinfector
Disinfectant
Wipe off/discard
Rinse
Assemble Dry
Wipe off and discard filter, see page 14. Assemble
There are two disinfection procedures for the expiratory cassette and associated parts, D1 and D2. In D1 (recommended) a Washer-Disinfector (EN-ISO-15883-1) is used, and in D2 a disinfectant is used.
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Sterilization with autoclave (NOT recommended) Dismantle
Wipe off/discard
Rinse Dry
Autoclave Dry Assemble
Autoclaving will reduce the lifetime of the expiratory cassette and is not recommend as a cleaning method. Sterilization is normally not necessary for the expiratory cassette, as it is not an invasive instrument, but when applied, use validated processes only. See further instructions about autoclaving on page 19.
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2.2 PREPARATIONS AND DISMANTLING
2.2.2 REMOVE THE EXPIRATORY CASSETTE SERVO-i
Dismantle
Wipe off/discard Rinse D1
D2
WasherDisinfector
Disinfectant
Rinse
Dry Assemble
2.2.1 PREPARATIONS - Switch off the ventilator using the switch on the rear of the User Interface. - Disconnect the ventilator from the power and gas supply. - Disconnect any optional equipment from the power supply and from the ventilator.
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- Lift the locking handle and pull out the patient unit. - Press the button on the expiratory cassette, tilt it upwards and remove.
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SERVO-s
- Press the locking arm on the rear to tilt the User Interface. - Press the button on the expiratory cassette, tilt it upwards and remove.
WARNING! After removing the expiratory cassette, do not pour any fluid into the expiratory cassette compartment. Avoid contact with electrical connectors.
IMPORTANT: The expiratory cassette can be exchanged between different SERVO-i/s ventilator systems. The ventilator may be used immediately* by connecting a clean expiratory cassette.
* After replacing the expiratory cassette, a Pre-use check must be performed (except in emergencies, when it should be performed as soon as possible).
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2.3 WIPING AND DISCARDING
Dismantle
Wipe off/discard Rinse D1
D2
WasherDisinfector
Disinfectant
Rinse
Dry
Caution: Do not immerse battery, CO2 analyzer, or Y sensor module (SERVO-i only) in any fluid.
2. Discard disposable items: - Servo Duo Guard viral/bacterial filter - Servo Humidifier/HME - Y sensors (SERVO-i only) - disposable patient tubing Regularly check that the fan filter looks clean (i.e. black). If dusty, remove (snap off/snap on) and rinse in water. Shake out, ensuring that the filter is free from excess water. This is all the cleaning that is required when a Servo Duo Guard filter (or equivalent) is used.
Assemble
1.
Wipe the ventilator and all removable parts with a soft lint-free cloth moistened in soap & water or detergent-based disinfectant.
Note: In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl alcohol (70%). Avoid contact with electrical contacts.
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2.3.1 RINSE BEFORE DISINFECTION
Dismantle
Wipe off/discard
IMPORTANT: Rinsing the cassette in water (<35°C/95°F) immediately after use may be a useful alternative to disinfection. Immediate rinsing can remove particles and reduces the risk of cross-contamination between patients.
Rinse D1
D2
WasherDisinfector
Disinfectant
Rinse
Dry Assemble
If rinsing before disinfection is not included in the washer disinfector program: - Rinse the parts thoroughly in water (<35°C/95°F). - Let the water flow through the parts.
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2.4 DISINFECTION PROCEDURES
2.4.1 WASHER-DISINFECTOR (D1)
Dismantle
Wipe off/discard Rinse D1
D2
WasherDisinfector
Disinfectant
Rinse
- Wash the parts with water only in a washer-disinfector at a temperature of 85-95°C (185-203°F).
Dry Assemble
IMPORTANT: The expiratory cassette is a precision instrument and must be handled carefully. After disinfection procedure, all parts must be dried before use. If the expiratory cassette is not dry it may not pass the Pre-use check.
1 - Place the expiratory cassette on its side with the electrical connector (1) uppermost as shown in the picture above.
Notes: The water pressure in the washer-disinfector should not exceed 1.5 bar. The maximum water flow should not exceed 10 l/min. The water must have free passage through the cassette.
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2.4.2 DISINFECTANT (D2)
Let the parts soak in disinfectant such as - Alcohol (ethyl or isopropyl alcohol 70%) - Cidex OPA - Hexanios G+R - Aniosyme DD1 - Gigazyme Plus - Anioxyde 1000
IMPORTANT: Follow the disinfectant manufacturer’s recommendations and instructions, otherwise the cassette may be damaged.
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2.4.3 RINSE AFTER DISINFECTION (D2)
- Rinse the parts thoroughly in water to remove all traces of disinfectant. Let the water flow through the parts. - Carefully shake and tilt the cassette, turn upside down and repeat. - Repeat these steps at least 5-7 times.
IMPORTANT: Mineral deposits from disinfectant on the expiratory cassette affect the function. It is important to rinse the expiratory cassette thoroughly. Residues from chemicals can affect the patient, cause leakage and extra stress on the material.
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2.4.4 DRYING ALTERNATIVES
Recommended position in a drying cabinet
Dismantle
Wipe off/discard Rinse D1
D2
WasherDisinfector
Disinfectant
Recommended position in room air Rinse
Dry Assemble
The expiratory cassette must be dried before use (if not dry, the expiratory cassette may not pass the Pre-use check). There are several drying alternatives for the expiratory cassette: - Carefully shake/tilt the cassette (5-7 times), or - Drying cabinet 1 hour in maximum 70°C (158°F); if available, connect a 22 mm air hose to the expiratory cassette for extra drying effect.
If the Pre-use check is not passed after drying then: - Run the cassette in a SERVO-i/s ventilator with a test lung for 10 minutes, or - Dry the cassette in room air (if no drying cabinet is available) 12-24 hours, depending on surrounding conditions.
Caution: Never dry the cassette by applying high-pressure air as the internal tubing may be damaged.
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Note: Drying may not be necessary if the washer-disinfector has a drying phase.
2.5 STERILIZATION PROCEDURES (NOT RECOMMENDED)
Rubber parts should be autoclaved in a validated process, typically at a temperature of 121°C (250°F). 2.5.5 DRYING AFTER AUTOCLAVING For drying alternatives, see page 18 .
An autoclave may be used to sterilize the expiratory cassette but it is normally not necessary, as the expiratory cassette is not an invasive instrument. 2.5.1 NUMBER OF CYCLES IN THE AUTOCLAVE The expiratory cassette will last at least: 100 autoclaving cycles with 4-7 minutes sterilization time at 134ºC (273ºF). 50 autoclaving cycles with 18 minutes sterilization time at 134ºC (273ºF). 2.5.2 RINSE Rinse the parts thoroughly in water (<35°C/95°F). Let the water flow through the parts to remove organic matter, e.g. blood, and other residues. 2.5.3 DRYING BEFORE AUTOCLAVING Before placing the expiratory cassette in an autoclave, make sure that no water remains inside the cassette. For drying instructions, see page 18. 2.5.4 AUTOCLAVE Instrument parts should be autoclaved in a validated process, typically at a temperature of 134°C (273°F) for 4-7 minutes. SERVO-i/s, User's Manual English language 1.8
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2.6 ASSEMBLING
SERVO-s
Dismantle
Wipe off/discard
Rinse
CLICK WasherDisinfector
Disinfectant
- Hinge the expiratory cassette and press it firmly down into lock position.
Rinse
WARNING! Make sure that the cassette clicks into position. Check that it cannot be moved upwards and that the button on top of the cassette is completely ejected.
Dry Assemble
2.6.1 RE-INSERTING THE EXPIRATORY CASSETTE
- Note on a log sheet that a routine cleaning has been performed. Refer to hospital guidelines.
SERVO-i 2.6.2 PRE-USE CHECK After cleaning, always perform a Pre-use check. For more information, please refer to the SERVO-i/s User's Manual.
CLICK
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If the Pre-use check fails: - Carefully shake/tilt the cassette (5-7 times). - Run the cassette in a SERVO-i/s ventilator with a test lung for 10 minutes. - Re-do the Pre-use check.
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2.7 SERVO ULTRA NEBULIZER CLEANING
2.7.1 PREPARATION
Cleaning should be done after each patient or according to hospital routine. Perform a function test of the SERVO Ultra Nebulizer after the cleaning. Refer to the SERVO-i/s User's Manual. Preparation
Wipe off/discard
Disconnect the Servo Ultra Nebulizer from the ventilator.
Rinse
2.7.2 WIPING AND DISCARDING
WasherDisinfector
Disinfectant
Autoclave
Only the T-piece and nipples can be autoclaved. The medication cup must not be disposed of with ordinary waste.
- Unscrew the T-piece and discard the medication cup. - Empty the buffer water from the nebulizing chamber. IMPORTANT: Do not autoclave or use a washer-disinfector when cleaning the nebulizing chamber.
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