Users Manual
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User's Manual SERVO-n Ventilator System v2.1
| TABLE OF CONTENTS |
TABLE OF CONTENTS
1 Introduction 2 System Overview 3 Operation overview 4 Displaying and saving data 5 Ventilation modes and therapies 6 Ventilatory settings and functions 7 Alarm handling 8 Service & Settings 9 Technical data 10 Index
SERVO-n Ventilator System v2.1, User's Manual Infologic 1.52.1.5
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| TABLE OF CONTENTS |
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SERVO-n Ventilator System v2.1, User's Manual Infologic 1.52.1.5
| Introduction | 1 |
1 Introduction Table of contents
1.1 1.2 1.3
SERVO-n Ventilator System v2.1, User's Manual
Device description Safety guidelines Version and Configurations
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6 8 13
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1.1 Device description
1.1.2 Intended use
1.1.1 Device components
The SERVO-n ventilator system is: • intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
The ventilator system consists of: 1. a user interface for setting ventilation modes and therapies, displaying data and indicating alarms 2.
a patient unit for mixing gases and controlling gas delivery
3.
a patient circuit for delivering and exchanging gases
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• to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: • to provide monitoring of the patient's breathing drive • to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
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• to be used only by healthcare providers
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• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube
SERVO-n Ventilator System v2.1, User's Manual
| Introduction | 1 |
1.1.3 User's Manual
1.1.5 Disclaimers
This manual summarizes the functions and safety features of the ventilator system. It is not all-inclusive and should not be seen as a substitute for training.
Non-professional servicing: Maquet has no responsibility for the safe operation of the ventilator system if installation, service or repairs are performed by persons other than Maquet authorized personnel.
1.1.4 Servicing Guidelines CAUTIONS: • Regular service: The 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 ventilator system must be recorded in a service log in accordance with hospital procedures and local and national regulations. • Service contract: It is strongly recommended that all service on the ventilator system should be performed as part of a service contract with Maquet.
Note: Modifications of the ventilator system during the actual service life require an evaluation of the requirements of the IEC 60601-1 standard.
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| 1 | Introduction |
1.2 Safety guidelines 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.
Important: Indicates information intended as help to operate the equipment or its connected devices easily and conveniently.
Note: Indicates information requiring special attention.
1.2.1 General WARNINGS! • The ventilator system may be operated only by authorized personnel who are properly trained in its use. It must be operated according to the instructions in this User´s Manual. • After unpacking, perform a routine cleaning and a pre-use check. • Always perform a pre-use check before connecting the ventilator system to a patient. • Secure all tubing and cables to avoid the risk of unwanted movement of the equipment. • If any of the following occurs, discontinue use of the ventilator system and contact a service technician: - unfamiliar pop-up windows on the screen - unfamiliar sounds - any unfamiliar or unexplained event - alarms that cannot be resolved • Make sure that a resuscitator is readily available. • Positive pressure ventilation can be associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment. • Ventilation must be started manually when a patient is connected to the ventilator system. • The inspiratory channel may be contaminated if the safety valve is opened when the patient is coughing. • Keep the patient unit upright during use.
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SERVO-n Ventilator System v2.1, User's Manual
| Introduction | 1 |
• Do not cover the ventilator system in any way, since the functioning of the equipment may be adversely affected. • Do not modify or remove any original parts. • The ventilator system must not be used during radiotherapy, since this may cause system malfunction. • The ventilator system must not be used in a hyperbaric chamber. • The ventilator system must be kept away from magnetic resonance imaging (MRI) equipment. • When the ventilator system is used with MCare Remote Services, use only network equipment that is safe and complies with the relevant electrical and EMC standards such as IEC 60950. Note: The network cable is excluded from this requirement. • 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. • Use only the Maquet approved active humidifiers. Use of non-approved active humidifiers may result in higher gas temperatures and increase resistance in filters. • During humidification, carefully monitor the airway pressure. Increased airway pressure could result from a clogged filter. Replace the filter if the expiratory resistance increases or according to the instructions for the filter, whichever comes first. SERVO-n Ventilator System v2.1, User's Manual
• Service, repair and installation may only be performed by Maquet authorized personnel.
CAUTIONS: • In USA, Federal law restricts this device to sale by or on the order of a physician. • Never leave the patient unattended when connected to the ventilator system. • Before use, make sure the system version displayed under SYSTEM STATUS/General corresponds to the system version described in the User's Manual. • Maquet has no responsibility for the safe operation of the ventilator system if the requirements specified in Intended use on page 6 are not followed. • When lifting or moving the ventilator system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions. The weight is specified on the ventilator system. • The expiratory channel and expired gas from the exhaust port may be contaminated. • During operation any water traps must be checked regularly and if necessary emptied. • All technical documentation is available for use by Maquet authorized personnel. • When using the MCare Remote Services function, instal the network cable so that there is no risk of anyone tripping over it.
Important: 9
| 1 | Introduction |
• Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. • The ventilator system must be installed and put into service according to the EMC declaration. • Securely attach all cables, etc, to minimize the risk of unintentional disconnection. • While the ventilator system is in use, the wheels of the mobile cart must be locked and the mobile cart must be in a horizontal position. • When the ventilator system is connected to a patient: - Do not lift or disconnect the expiratory cassette.
• Do not simultaneously touch the patient and any accessible connector contacts. • Do not solely rely on the use of an external monitor to determine the status of the patient and the ventilator system. • Extra care should be taken when handling tubes, connectors and other components of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended. • Contact a Maquet representative regarding decommissioning of the equipment.
- Continuously monitor the settings and measurements displayed on the screen. • Always use a heat and moisture exchanger (HME) or an active humidifier to prevent dehydration of lung tissue. • If a heated patient circuit is not used in the system, a water trap must be used on the expiratory tube to avoid condensation in the system when an active humidifier is used. During operation the water traps must be checked regularly and if necessary emptied. • Use an inspiratory filter when ventilating a highly infectious patient. • All excess fluids must be disposed of according to hospital routines.
Notes:
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SERVO-n Ventilator System v2.1, User's Manual
| Introduction | 1 |
1.2.2 Power supply WARNINGS! • The power cord must be connected only to an AC mains power outlet with protective earth to avoid the risk of electric shock. • The power supply cord must be plugged directly into the mains power outlet without the use of any multiple socket outlets. If a multiple socket outlet is used together with other products, total leakage current might be exceeded in the event of a fault in the protective earth.
CAUTIONS: • Do NOT use antistatic or electrically conductive tubing with this system. • Avoid contact with external electrical connector pins. • Unused module compartments should always contain a dummy module to protect the electrical connector pins from spillage and dust.
Important: In case of total loss of power during ventilation, an alarm will sound for 2 minutes. When power is restored, the ventilator system will start in the same state and with the same settings as before the power loss.
Notes: • When the system is connected to an external power supply, all connected battery modules are being recharged. This does not affect ventilation.
SERVO-n Ventilator System v2.1, User's Manual
• Batteries can be added to available slots during operation.
Battery WARNINGS! • To guarantee reliable battery backup, two fully charged battery modules must be connected at all times. • Dispose of batteries according to local regulations and not with ordinary waste.
Important: • If a battery status message is displayed on the screen, go to SYSTEM STATUS/Batteries for detailed information. If no action is taken, the battery operation time may be unreliable. • Always replace batteries when the ventilator system provides notification of imminent expiration or of diminished operating capacity. • Do not disconnect and store battery modules over long periods of time because this will degrade their capacity. If battery modules need to be stored for short periods of time (up to one week), then store them fully charged. • Check battery in SYSTEM STATUS/Batteries window to ensure safe battery operation. Always charge the battery before use. • When not in use, the ventilator system should always be connected to the mains power to ensure fully charged batteries.
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| 1 | Introduction |
1.2.3 Fire hazard
1.2.5 Auxiliary equipment
WARNINGS! • Keep all sources of ignition away from the ventilator system and the oxygen hoses.
CAUTION: Measurements of numerical values that have been processed by auxiliary equipment: • may be inaccurate if equipment not authorized by Maquet is used • should be disregarded if they conflict with information on the ventilator screen • must not be used as a substitute for therapeutic or diagnostic decisions.
• Do not use a ventilator system with worn or frayed gas supply hoses or hoses that have been contaminated by combustible materials such as grease or oil. • Oxygen-enriched gas is extremely flammable: if a burning odor is detected, disconnect the oxygen supply and mains power and remove the batteries. • Make sure that both the mains power outlet and the power supply connector are accessible.
1.2.4 Gases
Note: Accessories, supplies, and auxiliary equipment used with the ventilator system should: • be recommended by Maquet • meet IEC 60601-1 standards • meet IEC standards as a whole system
WARNING! The ventilator system must not be used with helium. Refer to section Ventilator system on page 173.
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SERVO-n Ventilator System v2.1, User's Manual
| Introduction | 1 |
1.3 Version and Configurations This manual applies to version 2.1 of the SERVO-n ventilator system. The ventilator system has a number of patient categories and ventilation modes available, both for invasive and non invasive ventilation.
SERVO-n Ventilator System v2.1, User's Manual
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| 1 | Introduction |
1.3.1 Available modes and functions Patient category Modes/Functions Neonatal
Pediatric
PC
X
X
PRVC
X
X
VC
-
X
Bi-Vent/APRV
O
O
PS/CPAP
X
X
VS
X
X
NAVA *
X
X
Automode • PC ⇄ PS • PRVC ⇄ VS • VC ⇄ VS
O O -
O O O
SIMV • (PC) + PS • (PRVC) + PS • (VC) + PS
X X -
X X X
NIV PC
O
O
NIV PS
-
O
NIV NAVA *
O
O
Nasal CPAP
X
X
High Flow therapy
O
O
Y sensor *
X
X
CO2 analyzer *
O
O
SERVO COMPASS
O
O
Nebulizer
X
X
Alarm output connection
O
O
* excluding module
X = standard
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- = not applicable
O = option
SERVO-n Ventilator System v2.1, User's Manual
| System Overview | 2 |
2 System Overview Table of contents
2.1 2.2 2.3 2.4 2.5
SERVO-n Ventilator System v2.1, User's Manual
Ventilator Patient unit Patient circuit configurations User interface Transport
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16 18 23 27 35
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| 2 | System Overview |
2.1 Ventilator The ventilator consists of a user interface and a patient unit. Air and O2 may be supplied by a medical pipeline system, a compressor, or by gas cylinders. Ensure that the patient unit is firmly fixed to the mobile cart via the clamps and locking clamp.
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SERVO-n Ventilator System v2.1, User's Manual
| System Overview | 2 |
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3 2
4 5
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6 7
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10 1.
User interface
2.
Patient unit
3.
Expiratory inlet
4.
Inspiratory outlet
5.
Emergency air intake
6.
Patient circuit
7.
Module compartment
8.
User interface control cable
9.
Air and O2 supply
WARNING! For safety reasons, ensure that user interface control cable is securely fastened by tightening the locking nuts on the connectors properly.
CAUTIONS: • The emergency air intake must not be blocked or covered. • Lock the wheels if the ventilator system is not to be used during transportation.
10. Wheel lock
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| 2 | System Overview |
2.2 Patient unit
1 2 3 4
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14 15
17 18
20
5
21
6 7 8
22 19
9 11 12
10
24 23
25 26
27
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SERVO-n Ventilator System v2.1, User's Manual
| System Overview | 2 |
1.
Expiratory outlet
2.
AC mains power LED, blue
3.
Power on LED, green
4.
On/Off switch The switch must be pulled downwards before it can be switched.
5.
RS-232 connectors
6.
Fuse for external DC power
7.
External +12V DC inlet
8.
User interface control cable connector
9.
AC mains power source connector with fuse
27. Serial number label
2.2.1 Handling modules Insert a module into the patient unit. Ensure that the module is fully inserted so that the release button returns to a completely closed position.
10. Potential equalization terminal 11. Alarm output connection 12. Cooling fan with filter 13. Lock for inspiratory channel cover 14. Gas inlet for air 15. Gas inlet for O2 16. Inspiratory channel cover 17. Inspiratory outlet 18. Emergency air intake 19. Module compartment
To remove a module: • Pull the lever slightly and press the release button while continuing to pull the lever until the module is released from the ventilator system. • Remove the module from the ventilator system.
20. Expiratory inlet 21. Nebulizer connector 22. Module release levers 23. Expiratory cassette 24. Expiratory inlet with moisture trap 25. Fuse, power label - Fuse label - AC mains power voltage - Potential equilization terminal information 26. Gases and gas inlet pressure label - Air - O2 - Allowed gas inlet pressures SERVO-n Ventilator System v2.1, User's Manual
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| 2 | System Overview |
2.2.2 Symbols on patient unit Symbol
Description
Symbol
Description
Consult accompanying documentation
CE label-indicates compliance with the requirements of the Medical Device Directive 93/42/EEC
Press to close/open
CSA label-Indicates compliance with Canadian and US standards
Lock
Type B-indicates classification according to IEC 60601-1
Unlock
Type BF applied part - indicates classification according to IEC 60601-1
Serial number
Potential equalization terminal
Weight of patient unit with user interface and ventilator including its safe working load.
Nebulizer connector
UDI Label - Unique Device Identification. See technical specifications, page 203.
RS-232/Serial port - connector for data communication Ingress protection, IP21 User interface connector
Order number
MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment.
Fuse for external 12V DC
- +
External 12V DC input
12V
- +
Battery Expiratory gas flow from the patient Inpiratory gas flow to patient Mains power On/Off Mains connected, batteries charging Gas exhaust port-exhaust gas flow from ventilator system Alarm output connection Special waste
Caution Consult instructions for use
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SERVO-n Ventilator System v2.1, User's Manual
| System Overview | 2 |
Notes: • Special waste. This product contains electronic and electrical components. Discard disposable, replaced and left-over parts in accordance with appropriate industrial and environmental standards. • Potential equalization terminal. The potential equalization terminal is designed for the connection of a potential equalization conductor according to DIN 42 801 and IEC 60601-1. The function of the potential equalization terminal is to equalize potentials between the ventilator system and other medical devices that can be touched simultaneously. The potential equalization terminal must not be used for a protective earth connection.
SERVO-n Ventilator System v2.1, User's Manual
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