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User´s Manual SERVO-i VENTILATOR SYSTEM V6.1
| TABLE OF CONTENTS |
TABLE OF CONTENTS
1 Introduction 2 System Overview 3 Power supply 4 Operation overview 5 Monitor and record 6 Ventilation, modes and functions 7 NAVA 8 Alarms 9 Optional Accessories 10 System messages 11 Start-up configuration 12 Technical data 13 Definitions 14 Appendix • User interface 15 Certificates 16 Index
SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual Infologic 1.54.1.1
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| TABLE OF CONTENTS |
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual Infologic 1.54.1.1
| Introduction | 1 |
1 INTRODUCTION TABLE OF CONTENTS
1.1 1.2 1.3
SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
Device descriptions Warning, Caution, Important and Note Version and Configurations
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6 9 14
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1.1 DEVICE DESCRIPTIONS
1.1.3 INTENDED USE
This section provides general information about the SERVO-i Ventilator System along with guidelines for appropriate use.
The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or respiratory insufficiency.
1.1.1 DEVICE DIAGRAM 1.1.4 INTENDED USER The SERVO-i Ventilator System should be used only by those who: are a professional health care provider, and
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have received training in the use of this system, and 2
have experience with ventilation treatment.
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SVX-128a
1.1.2 DEVICE COMPONENTS The SERVO-i Ventilator System consists of the following components: 1. User Interface-for setting ventilation modes, displaying patient data, and indicating alarms 2.
Patient Unit-for mixing gases
3.
Patient Breathing System-for delivering and exchanging gases
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1.1.5 INTENDED USE ENVIRONMENT The SERVO-i Ventilator System should be used only: in hospitals in facilities whose primary purpose is to provide health care during transport of a patient within hospitals or health care facilities for interhospital transport if the conditions stated in the SERVO-i Interhospital Transport declaration (order no. 66 64 721) are fulfilled and an agreement with MAQUET is signed during MR examinations of patients if the conditions in the SERVO-i MR Environment declaration (order no. 66 71 670) are met and an agreement with MAQUET is signed.
1.1.7 SERVICING GUIDELINES CAUTIONS: Regular Service: The SERVO-i Ventilator System must be serviced at regular intervals by MAQUET authorized personnel who have received specialized training. Complete Service Records: All service performed on the SERVO-i Ventilator System must be recorded in a service log in accordance with hospital procedures and local and national regulations. Service Contract: We strongly recommend that all service on the SERVO-i Ventilator System should be performed as part of a service contract with MAQUET.
1.1.6 CLEANING AND MAINTENANCE Please refer to the SERVO-i/s Cleaning and Maintenance User's Manual.
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1.1.8 DISCLAIMERS Improper Use Environment MAQUET has no responsibility for the safe operation of SERVO-i Ventilator System if the Intended Use Environment requirements specified in this document are not followed. Nonprofessional Servicing MAQUET has no responsibility for the safe operation of the SERVO-i Ventilator System if installation, service or repairs are performed by persons other than MAQUET authorized personnel.
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1.2 WARNING, CAUTION, IMPORTANT AND NOTE Follow these safety guidelines. Additional warnings appear in context throughout this document. Information is highlighted with Warning, Caution, Important or Note, where: WARNING! Indicates critical information about a potential serious outcome to the patient or the user.
CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment.
1.2.1 GENERAL This manual summarizes the functions and safety features of the SERVO-i Ventilator System. It is not all-inclusive and should not be construed as a substitute for training. WARNINGS! Always perform a Pre-use check before connecting the ventilator to a patient. If any of the following occurs, discontinue use of the ventilator and contact a service technician: - Unfamiliar pop-up windows on the screen - Unresolvable alarms - Unfamiliar sounds - Any unfamiliar or unexplained event
Important: Indicates information intended to help you operate the equipment or its connected devices easily and conveniently.
Note: Indicates information requiring special attention.
SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
Keep the ventilator upright during use. When the ventilator is connected to a patient: - Do not lift or disconnect the expiratory cassette. - Continuously monitor the settings and measurements displayed on the screen.
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WARNINGS! The SERVO-i Ventilator System must be operated only by authorized personnel who are well trained in its use. It must be operated according to the instructions in this User´s Manual.
CAUTIONS: In USA, Federal law restricts this device to sale by or on the order of a physician.
Do not cover the ventilator in any way, since the functioning of the equipment may be adversely affected.
Refer to the Installation instructions to assemble the system or options to obtain a proper mechanical assembly.
When the ventilator is used for MCare Remote Service, use only network equipment that is safe and in compliance with the relevant electrical and EMC standards such as IEC-60950.
When lifting or moving the ventilator system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions.
Note: The network cable is excluded from this requirement.
Before use, make sure the system version displayed under Status corresponds to the system version described in the User´s Manual.
Always disconnect the network cable before starting ventilation when the ventilator is used for MCare Remote Service. Positive pressure ventilation can be associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment. The SERVO-i Ventilator System should not be used in MR environments unless the requirements described in the SERVO-i MR Environment Declaration (order no. 66 71 670) are met and an agreement with MAQUET is signed.
The expiratory channel and expired gas from the exhaust port may be contaminated.
Extra care should be taken when handling tubes, connectors and other parts of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended. When using the MCare Remote Service function, install the network cable so that there is no risk of anyone tripping over it.
The SERVO-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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CAUTIONS: When the ventilator is connected to a patient: - Do not leave the patient unattended.
Important: Always use heat and moisture exchanger (HME) or equipment to prevent dehydration of lung tissue.
- Make sure a resuscitator is readily available.
While in use the wheels of the carrier shall be locked and the carrier shall be in a horizontal position.
Do not modify or remove any original parts. MAQUET has no responsibility for the safe operation of SERVO-i Ventilator System if the Intended Use requirements specified in this document are not followed.
Securely attach all cables, etc, to minimize the risk of unintentional disconnection.
Contact a MAQUET representative regarding decommissioning of the equipment. Only accessories, supplies, and auxiliary equipment recommended by MAQUET should be used with the ventilator system. Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety.
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1.2.2 POWER SUPPLY
1.2.3 FIRE HAZARD
WARNINGS! The power cord must be connected only to a properly grounded AC electrical outlet.
WARNINGS! Keep the system and its gas hoses clear of all ignition sources.
To guarantee reliable battery backup, two fully charged battery modules should be installed at all times. Make sure there are at least two fully charged batteries installed at all times.
CAUTIONS: Do NOT use antistatic or electrically conductive tubing with this system.
Do not use the system with worn or frayed hoses or hoses that have been contaminated by combustible materials such as grease or oil. Oxygen-enriched gas is extremely flammable: if you detect a burning odor, disconnect the oxygen supply, mains power and remove the batteries. Make sure that both the mains power outlet and the power supply connector are accessible.
Avoid contact with external electrical connector pins. Unused module compartments should always contain an empty module to protect the electrical connector pins from spillage and dust.
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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1.2.4 GASES
1.2.5 AUXILIARY EQUIPMENT
CAUTION: The system is not intended to be used with any anesthetic agent.
CAUTIONS: Accessories, supplies, and auxiliary equipment used with the ventilator should: - be recommended by MAQUET
Important: Supplied gases shall meet the requirements for medical grade gases according to applicable standards. Maximum levels: Air 3 H2O < 7 g/m 3
Oil < 0.5 mg/m
Chlorine: must not be detectable Oxygen 3 H2O < 20 mg/m 3 Oil < 0.3 mg/m
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- meet IEC 60601-1-1 standards - meet IEC standards as a whole system If a scavenging system (i.e. gas evacuation) is connected to the ventilator, it must conform to ISO8835-3 guidelines for subatmospheric pressure and induced flow. Measurements of parameter values that have been processed by auxiliary equipment: - may be inaccurate if equipment not authorized by MAQUET is used - should be discounted if they conflict with information on the ventilator screen - must not substitute for therapeutic or diagnostic decisions
1. If the compressed air is generated by a liquid ring compressor there is a potential risk of chlorine in the supplied air. SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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| 1 | Introduction |
1.3 VERSION AND CONFIGURATIONS This manual applies to version 6.1 of the SERVO-i Ventilator System, which can be delivered in three configurations: SERVO-i Infant; SERVO-i Adult and SERVO-i Universal (Basic or Extended edition). Details about each configuration follow on page 15. 1.3.1 CONFIGURATIONS The Main Rotary Dial and Direct Access Knobs become inoperative for 2 seconds when the user reaches a defined safety limit for the parameter being adjusted.
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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1.3.2 WEIGHT RANGES SERVED BY EACH CONFIGURATION OF THE SERVO-i VENTILATOR SYSTEM Configuration
Weight range Invasive ventilation
Non invasive ventilation Adult range
NIV PC + PS Infant
NIV NAVA Infant NIV Nasal CPAP
SERVO-i Infant 0.5 kg – 30 kg
Not Applicable
3 kg – 30 kg
0.5 kg – 30 kg
0.5 kg – 10 kg
SERVO-i Adult
10 kg – 250 kg
10 kg – 250 kg
Not Applicable
Not Applicable
Not Applicable
SERVO-i Universal
0.5 kg – 250 kg 10 kg – 250 kg
3 kg – 30 kg
0.5 kg – 30 kg
0.5 kg – 10 kg
NIV = Non-Invasive Ventilation 1.3.3 SERVO-i VENTILATOR SYSTEM CONFIGURATIONS - LISTS THE AVAILABLE FUNCTIONS AND INDICATES IF INCLUDED OR OPTIONAL WITH EACH CONFIGURATION Infant
Standard Configuration
Adult
Options
UBE
Universal Basic Edition
Not applicable
UEE
Universal Extended Edition
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| 1 | Introduction |
UBE Heliox Nasal CPAP
UEE
UBE
UEE
SIMV (PRVC) + PS PRVC
Non Invasive Ventilation (NIV) Y Sensor Measuring CO2 Analyzer
SIMV (VC) + PS VC (Volume Control)
Nebulizer Bi-Vent Open Lung ® Tool (OLT) Automode
VS (Volume Support)
®
Stress Index
SIMV (PC) + PS PC (Pressure Control) PS/CPAP NAVA NIV NAVA
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
| System Overview | 2 |
2 SYSTEM OVERVIEW TABLE OF CONTENTS
2.1 2.2 2.3 2.4 2.5
SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
Ventilator | User Interface - Connections, labels and | symbols Navigating the User Interface | Patient Unit - Connections, labels and symbols | Intra-hospital transport and storage |
18 19 23 29 33
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2.1 VENTILATOR The User Interface is used to control ventilator settings. Settings may be adjusted using touchpads on the screen or a rotary dial. Breathing parameters are continuously measured and controlled. A difference between the actual measured value of a parameter and the preset or calculated value results in the adjustment of gas delivery to achieve the target value. The system has two gas modules, one for air and one for O2. Gases may be supplied by a medical pipeline system, a compressor, or by gas tanks. CAUTION: Lock the wheels if the ventilator is not to be used for transportation. Ensure that the ventilator is positioned into its locked position on the cart or holder used, to prevent unintentional movements.
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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2.2 USER INTERFACE CONNECTIONS, LABELS AND SYMBOLS The User Interface includes: a screen with active touchpads
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6
fixed keys
7 10
rotary dials
8 9
1.
Air and O2 supply
2.
Power cable
3.
User Interface
4.
Patient Unit
5.
Expiratory inlet
6.
Servo Duo Guard, viral/bacterial filter
7.
Inspiratory outlet
8.
Patient system
9.
Module compartment
10. Emergency air intake
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| 2 | System Overview |
2.2.1 USER INTERFACE DIAGRAM
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SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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2.2.2 USER INTERFACE COMPONENTS Refer to the User Interface Diagram for locations of the following numbered components: 1. Patient category
21. Additional settings 22. Additional measured values 23. Loudspeaker 24. Cable reel for the control cable
2.
Active mode of ventilation
25. Slot for Ventilation Record Card (side/rear view)
3.
Automode On/Off (option)
26. Screen rotation locking lever
4.
Admit patient/Entered patient data and admission date
27. Locking screw for alternative cart mounting
5.
Nebulizer On/Off (option)
6.
System status parameters
28. Panel holder for positioning on the Mobile Cart
7.
Fixed keys
29. Control cable (2.9 m long)
8.
Main Rotary Dial-used to select a menu touchpad or parameter box, to adjust values, and to confirm settings
30. Service connector
Special Function Keys-used to start special ventilatory functions
32. Locking arm for tilting the screen
9.
10. Direct Access Knobs-used for immediate adjustment of breathing parameters
31. On/Off switch (Set to On; when off, battery continues to charge) 33. Model number 34. Serial number 35. Manufacturing information
11. AC Power indicator (green) 12. Standby indicator (yellow) 13. Start/Stop (Standby) ventilation key 14. On/Off switch (rear side) 15. Slot for Ventilation Record Card (front view) 16. Luminescence detector-for automatically adjusting screen brightness 17. Informative text messages, which include a purple symbol when triggered by the patient 18. Alarm messages 19. Waveform area-for monitoring two to four individually scaled parameters, including a volume/pressure loop and a flow/volume loop 20. Measured values and alarm limits display (customizable) SERVO-i VENTILATOR SYSTEM V6.1, User´s Manual
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