Instructions for Use
166 Pages
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Page 1
Instructions for Use
Isolette 8000
WARNING To properly use this medical device, read and comply with these instructions for use.
Infant Incubator
Typographical conventions 1
Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.
Bullet points indicate individual actions or different options for action. –
Dashes indicate the listing of data, options, or objects.
(A) Letters in parentheses refer to elements in the related illustration.
Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, Cal, Air, or Audio Paused/Reset.
Screen reproductions The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.
A Letters in illustrations denote elements referred to in the text.
Trademarks Trademark
Trademark owner
Trademark
Trademark owner
Care-forMe™
Dräger
CaviCide®
Metrex Research Corporation
VueLink™
Philips Medical Systems
Infinity®
Dräger
Isolette®
Dräger
SoftBed™
Dräger
terralin® pro- Schülke & Mayr tect Google Earth™
Safety information definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.
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Instructions for Use Isolette 8000
Definition of target groups For this product, users, service personnel, and experts are defined as target groups. These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.
Users Users are persons who use the product in accordance with its intended use.
Service personnel Service personnel are persons who are responsible for the maintenance of the product. Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.
Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.
Instructions for Use Isolette 8000
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Instructions for Use Isolette 8000
Contents
Contents Typographical conventions... Trademarks... Safety information definitions... Definition of target groups...
2 2 2 3
For your safety and that of your patients. . .
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General safety information... 8 Product-specific safety information... 12 Application... 19 Intended use... 20 Environment of use... 20 Indications/contraindications... 20
Attaching the hood/shell assembly to the VHA stand... Attaching accessories... Installing the weighing system (accessory) . . . Installing the humidity system (option)... Installing the servo oxygen control system (option)... Installing the 100% oxygen calibration fixture (optional)... Installing the breathing hose holder (accessory)...
46 48 49 51 52 54 56
Getting started...
57
System start-up... Operational checkout procedure...
58 59
Front view... 22 Rear view... 23 Right side view... 24 Left side view... 25 Sensor module... 26 Isolette 8000 overview... 27 Oxygen system... 27 Humidity system (option)... 28 Condensation management system (option) . . 28 Weighing system (accessory)... 29 Functional description... 29 External devices... 30 Convenience outlets... 31 Abbreviations... 32 Symbols... 33 Technical definitions... 35
Operation...
71
Operating concept... 37
Alarms...
93
Front panel of controller... Screen... Hard keys... Soft keys... LED indicators...
38 39 40 41 43
Safety information... Alarm priority... Alarm indication... Disabling the alarm tone sequence...
94 94 95 96
Trends...
97
Assembly... 45
Trend display...
98
Unpackaging... 46 Proper assembly... 46
Configuration...
99
Overview... 21
Setting the temperature... 72 Setting the humidity (option)... 77 Setting the servo control oxygen (option)... 80 Manual control oxygen usage (option)... 82 Variable height adjustment... 83 Infant placement... 83 Scale measurements (accessory)... 84 X-ray tray usage... 87 Dräger Infinity Delta, Delta XL, and Kappa monitoring... 88 VueLink™ monitoring... 88 Oxygen sensor calibration (option)... 89 Scale calibration (accessory)... 91 System shut-down... 92
System configuration menu... 100 Instructions for Use Isolette 8000
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Contents
Problem solving... 103 Alarm messages... 104 Problems/alarm conditions without alarm messages... 114 System prompt messages... 115 Cleaning, disinfection, and sterilization... 119 Overview... 120 General cleaning... 120 Disinfecting... 121 Disassembly for cleaning... 121 Cleaning procedures... 126 Reassembly after cleaning... 130 Maintenance... 133 Overview... 134 Inspection... 135 Preventive maintenance... 136 Maintenance instructions... 139 Repair... 143 Disposal... 145 Disposing of the medical device... 146 Technical data... 147 Isolette 8000 system... 148 Humidity system (option)... 151 Oxygen control system... 151 Non-OIML/NAWI weighing system (accessory)... 152 OIML/NAWI weighing system (accessory)... 152 Rail accessory weight limitations... 153 Non-rail accessory weight limitations... 153 EMC Declaration... 154 List of accessories... 159 Accessories... 160 Consumables... 162 Index... 163
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Instructions for Use Isolette 8000
For your safety and that of your patients
For your safety and that of your patients General safety information...
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Strictly follow these instructions for use... 8 Maintenance... 8 Safety checks... 8 Accessories... 8 Sterile accessories... 9 Connected devices... 9 Not for use in areas of explosion hazard... 9 Safe connection with other electrical equipment... 9 Connection to other devices... 9 Patient safety... 10 Patient monitoring... 10 Functional safety... 10 Information on electromagnetic compatibility . . 11 Installing accessories... 11 Storing the instructions for use... 11 Training... 11 Restrictions for use... 11 Product-specific safety information... 12
Instructions for Use Isolette 8000
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For your safety and that of your patients
General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical device.
Strictly follow these instructions for use WARNING Risk of incorrect operation and of incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use" on page 20 and in conjunction with appropriate patient monitoring (see page 10). Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.
Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.
Safety checks The medical device must be subject to regular safety checks. See chapter "Maintenance".
Accessories WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in the current list of accessories. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.
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Instructions for Use Isolette 8000
For your safety and that of your patients
WARNING Risk of equipment damage and risk of injury Reusing, reprocessing, or sterilizing disposable items can lead to a failure of the medical device and cause injury to the patient. Do not reuse, reprocess, or sterilize disposable items. Disposable items were designed, tested, and manufactured for one-time use only.
Not for use in areas of explosion hazard WARNING Risk of fire The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.
Sterile accessories
Safe connection with other electrical equipment
CAUTION Risk of medical device failure and of patient injury
CAUTION Risk of patient injury
Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.
Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer.
Single-use accessories must not be reused, reprocessed, or resterilized.
Connection to other devices Connected devices WARNING Risk of electric shock and of device malfunction Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.
Instructions for Use Isolette 8000
Device combinations (Dräger devices + Dräger devices or Dräger devices + third-party devices) approved by Dräger (see instructions for use of individual devices) meet the requirements of the following standards: –
IEC 60601-1 (2nd or 3rd edition) Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance –
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic safety Collateral standard: Electromagnetic Compatibility - Requirements and Tests
–
IEC 60601-1-8 Medical Electrical Equipment Part 1-8: General requirements for basic safety Collateral standard: Alarm systems - General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems
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For your safety and that of your patients
If a device combination is not approved by Dräger, proper operation of the devices can be compromised. The operator must ensure that the device combination meets the applicable standards. Strictly observe instructions for use and assembly instructions of all connected devices.
Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –
Risks that are obvious to users
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Consequences of obvious improper use of the medical device
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Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous. CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.
Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.
Functional safety The essential performance consists of: –
Skin temperature regulation The skin temperature setting (target value) is compared to the actual skin temperature and is regulated.
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Air temperature regulation The air temperature setting (target value) is compared to the actual ambient air temperature and is regulated.
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O2 regulation The O2 value setting (target value) is compared to the actual ambient O2 concentration and is regulated.
The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied. WARNING Risk of malfunction Unauthorized modifications to the medical device may lead to malfunctions. This medical device must not be modified without the permission of Dräger.
Patient monitoring The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition. 10
Instructions for Use Isolette 8000
For your safety and that of your patients
Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2:
Installing accessories CAUTION Risk of device failure Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device.
Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 154.
Strictly observe instructions for use and assembly instructions.
Portable and mobile radio frequency communication equipment can affect medical electrical equipment.
Storing the instructions for use
WARNING Risk of electric shock Do not connect connectors with an ESD warning symbol and do not touch their pins without implementing ESD protective measures. Such protective measures can include antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. All users concerned must be instructed in these ESD protective measures. WARNING Risk of device failure Electromagnetic fields can compromise proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as: - Mobile phones - Radio frequency electrosurgical equipment
CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.
Training Training for users is available from the Dräger organization responsible, see www.draeger.com.
Restrictions for use CAUTION Device for use in healthcare facilities only and exclusively by persons with specific training and experience in its use. CAUTION Federal law (U.S.) restricts this device to sale by or on the order of a physician.
- Defibrillators - Shortwave therapy equipment Use radio frequency equipment only with a sufficient safety margin of at least 20 cm (7.9 in). Instructions for Use Isolette 8000
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For your safety and that of your patients
Product-specific safety information Electrical precautions
Explosion precautions
WARNING Risk of electric shock
WARNING Risk of explosion
The total electrical current leakage of all items powered through the incubator must be less than 300 µA for 120 V AC/100 V AC systems and less than 500 µA for 230 V AC systems.
Do not use in the presence of flammable anesthetics.
WARNING Risk of electric shock The potential for electrical shock exists with electrical equipment. Establish policies and procedures to educate your staff on the risks associated with electrical equipment. WARNING Risk of electric shock Due to the risk of electrical shock hazard, only properly trained personnel with appropriate service documentation should service the device. WARNING Risk of electric shock To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth (protective ground). CAUTION Risk of equipment damage To prevent equipment damage or accidental power disconnections, do not connect a power cable from the incubator controller directly to an AC wall socket. Always provide power to the incubator by using the power cable coming directly from the stand.
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WARNING Risk of explosion Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. Keep matches, and all other sources of ignition, out of the room in which the incubator is located. WARNING Risk of explosion Small quantities of flammable agents, such as ethyls and alcohol, left in the incubator may result in a fire hazard in oxygen enriched environments. Ensure that the incubator is free of such agents and that oxygen levels are at near room ambient levels. WARNING Risk of explosion A fire and explosion hazard exists when performing cleaning or maintenance procedures in an oxygen-enriched environment. Make sure that the oxygen supply is turned off and the oxygen hose to the incubator is disconnected when performing cleaning and maintenance procedures. Switch off or disconnect oxygen supplies during periods of non-use.
Instructions for Use Isolette 8000
For your safety and that of your patients
EMC precautions WARNING Risk of electric shock The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. All medical accessory equipment in the patient vicinity must comply with the safety requirements of International Electrotechnical Commission (IEC) 60601-1 and must have the relevant safety certifications. CAUTION Risk of injury or equipment damage
CAUTION Risk of injury or equipment damage Medical electrical equipment needs special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this manual. In addition, portable and mobile RF communications equipment can affect medical electrical equipment. CAUTION Risk of injury or equipment damage Castor wheels do not control all the ESD characteristics of the device on which they are mounted. They do, however, prevent the build-up of charge on the wheels from friction during motion.
Use of accessories other than those listed and approved for use in this product as original or replacement items may result in increased emissions or decreased immunity.
ESD is a product of the environment and only the user/owner can control the ESD in that environment. Control is accomplished by maintaining a conductive floor, equipping employees with ESD clothing and control devices, etc.
CAUTION Risk of injury or equipment damage
Oxygen precautions
The equipment shall not be used adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved. CAUTION Risk of injury or equipment damage Devices connecting to the serial port must be compliant with EN 60601-1-2, the EMC requirement for Medical Devices. CAUTION Risk of injury or equipment damage The incubator display may go blank during an episode of static discharge to the sensor module.
Instructions for Use Isolette 8000
WARNING Risk of death or serious injury Improper use of supplemental oxygen may be associated with serious side effects including blindness, brain damage, and death. The risks vary with each infant. The qualified attending physician should prescribe the method, the concentration, and the duration of oxygen administration. WARNING Risk of death or serious injury If it is necessary to administer oxygen in an emergency, notify the attending physician immediately. Noncompliance may result in death or serious injury.
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For your safety and that of your patients
WARNING Risk of death or serious injury
WARNING Risk of fire
The oxygen concentration inspired by an infant does not accurately determine the partial pressure of oxygen (pO2) in the blood.
Because oxygen use increases the risk of fire, do not place auxiliary equipment that produces sparks in an incubator.
When deemed advisable by the attending physician, measure blood pO2 by accepted clinical techniques.
WARNING Risk of death or serious injury
WARNING Risk of death or serious injury After each change of oxygen flow, allow at least 30 min to achieve new concentrations. WARNING Risk of death or serious injury Oxygen levels within the incubator hood environment may be affected when the hand ports or access panels are opened. Make sure that all hood hand port gaskets and tubing grommets are properly installed. Any open gaps in the incubator hood may reduce the incubator internal oxygen. WARNING Risk of death or serious injury Compressed gas cylinders, such as oxygen cylinders, can become hazardous projectiles if the gas is released rapidly due to damage or other causes. Securely fasten the cylinder. WARNING Risk of death or serious injury Disconnect the incubator from the hospital oxygen source when oxygen is not in use.
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The oxygen sensor is a sealed unit that contains potassium hydroxide electrolyte. If the sensor develops a leak, discard it immediately. If contact with the skin or clothing occurs, rinse the area with a large quantity of water. In case of eye contact, flush the eye immediately for at least 15 min, holding the eye open, and call a physician. WARNING Risk of death or serious injury Use only Dräger Medical recommended oxygen sensors for proper operation. WARNING Risk of death or serious injury Inspect gas/oxygen service components at regular service intervals for signs of corrosion or damage. WARNING Risk of death or serious injury Routinely inspect oxygen cells for signs of degradation or leakage, and replace if necessary. WARNING Risk of death or serious injury Use of anesthetic agents can interfere with oxygen monitor accuracy.
Instructions for Use Isolette 8000
For your safety and that of your patients
CAUTION Risk of patient injury
WARNING Risk of death or serious injury
The administration of oxygen may increase the noise level for the baby within the incubator.
When the front or rear access panel is open, the temperature display may not accurately reflect the incubator temperature.
Humidity precautions
Do not leave the access panel open longer than essential.
WARNING Risk of death or serious injury Make sure that all hand port gaskets and tubing grommets are properly installed on the hood. Any open gaps in the incubator hood reduce the incubator internal relative humidity. CAUTION Risk of injury Fill the reservoir to the Maximum Filling Limit line. Do not overfill. Water spillage may result. Safety tips WARNING Risk of death or serious injury
WARNING Risk of death or serious injury Positively secure all hand port latches and access panel locking knobs to avoid accidental opening. WARNING Risk of death or serious injury For infant safety, do not leave the infant unattended when the access panels or hand ports are open. WARNING Risk of death or serious injury
Incubator misuse may result in harm to an infant. Only properly trained personnel should use the incubator as directed by an appropriately qualified attending physician aware of currently known risks and benefits.
The use of infant seats or other accessories within the incubator that can alter the airflow pattern may affect temperature uniformity, temperature variability, the correlation of the incubator temperature reading to center mattress temperature, and infant skin temperature.
WARNING Risk of death or serious injury
WARNING Risk of death or serious injury
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.
If airflow slots in the incubator are blocked during clinical usage, patient safety and incubator performance may be compromised.
WARNING Risk of death or serious injury
Keep the airflow slots clear of obstructions, such as blankets and stuffed animals.
Do not raise the hood at any time while the infant is in the incubator. Gain access to the infant by the access panels and hand ports.
Instructions for Use Isolette 8000
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For your safety and that of your patients
WARNING Risk of death or serious injury
WARNING Risk of death or serious injury
When the access panels are open, a curtain of warm air flows along the length of the mattress toward the top of the access panel openings. The temperature of this air curtain is higher than the typical incubator air temperature; therefore, keep the infant clear of this warm air path.
For proper operation of the incubator, use only skin temperature probes from Dräger.
WARNING Risk of death or serious injury If using surgical covers or blankets over the infant, ensure that they do not interfere with the warm air curtain or side vents. This may cause heat-induced injury and burns. WARNING Risk of death or serious injury To avoid overheating the infant due to direct radiation, do not position the incubator in direct sunlight or under other sources of radiant heat. WARNING Risk of death or serious injury Use of phototherapy devices with the incubator may affect hood wall temperature, incubator temperature, and infant skin temperature.
WARNING Risk of death or serious injury Never place objects taller than the top of the castor wheels beneath the incubator stand. Placement of objects there could interfere with the stability of the stand. WARNING Risk of death or serious injury Always use 2 people when moving the incubator and patient together. When moving the incubator within the same floor space: – Check that the patient is secured safely in the device – Remove or secure all loose system components – Lower the VHA stand, I.V. pole, and shelves to their lowest position – Close all drawers – Remove all accessories from the rails WARNING Risk of death or serious injury
WARNING Risk of death or serious injury
For optimum stability, always lower the incubator to its lowest position before moving the device. Make sure that items placed on the monitor shelf are properly secured.
Phototherapy lights placed over the top of the incubator hood may interfere with upward travel of the VHA stand.
WARNING Risk of death or serious injury
To prevent this interference, always remove the phototherapy light before positioning the stand.
Lateral or angular movement (across the width) can result in inadvertent tip-over if the wheels encounter any obstacle. Always push or pull the incubator forward or backward in a straight line along the length of the stand (from the ends).
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Instructions for Use Isolette 8000
For your safety and that of your patients
WARNING Risk of death or serious injury
WARNING Risk of death or serious injury
To avoid possible tip-over or damage to adjacent carts, infusion stands, shelves, etc., keep at least a 30 cm (12 in) perimeter area clear around the stand.
Do not insert any object into any of the ventilation holes or any other opening on the Isolette 8000.
WARNING Risk of death or serious injury For optimum incubator stability, always lock all stand wheels. Do not leave the device unattended when parking on an incline. WARNING Risk of death or serious injury To prevent accidental disconnection, secure all patient leads, infusion lines, and ventilator tubing to the mattress with sufficient excess length to allow for the full range of mattress height adjustment. WARNING Risk of death or serious injury Accessories such as trays, baskets, and shelves should never be used to hold an infant and should not be overloaded due to tip-over hazard. WARNING Risk of death or serious injury Always close drawers when not in use, particularly when the incubator is being moved. WARNING Risk of death or serious injury The drawers and rail system are labeled for acceptable weights. Do not exceed these weight limitations.
Instructions for Use Isolette 8000
WARNING Risk of death or serious injury To prevent possible trip and fall hazards, always properly secure the power cable. WARNING Risk of death or serious injury Before moving the device, always ensure that the mattress is level, i.e., not in the Trendelenburg or Reverse Trendelenburg position. WARNING Risk of death or serious injury To place the bed in Trendelenburg or Reverse Trendelenburg, always tilt one end of the bed and keep the opposite end in the lowest position. Elevating both ends simultaneously is not recommended. WARNING Risk of death or serious injury Before placing the bed in Trendelenburg or Reverse Trendelenburg, ensure that patient extremities are not caught between the bed and the hood walls. WARNING Risk of death or serious injury Use caution when opening doors fitted with tubing grommets so that patient lines or cables do not become accidentally disconnected.
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For your safety and that of your patients
CAUTION Risk of injury or equipment damage. Do not connect the Isolette 8000 to a surge suppressor.
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Instructions for Use Isolette 8000
Application
Application Intended use... 20 Environment of use... 20 Indications/contraindications... 20
Instructions for Use Isolette 8000
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Application
Intended use The Isolette 8000 infant incubator provides a controlled environment for both premature and fullterm babies up to a maximum of 10 kg (22 lb). It controls temperature, oxygen (optional), and humidity (optional).
Environment of use The Isolette 8000 infant incubator can be used in any department of the hospital that provides neonatal and infant care, including all levels of the Neona-
tal Intensive Care Unit (NICU), Special Baby Care Unit, Step Down Nursery, Newborn Nursery, and Pediatrics.
Indications/contraindications The Isolette 8000 infant incubator is indicated for thermoregulation and controlling oxygen (optional) and humidity (optional). The Isolette 8000 infant incubator is not intended for home use.
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Instructions for Use Isolette 8000