Instructions for Use
104 Pages
Preview
Page 1
Instructions for Use
TI500
WARNING To properly use this medical device, read and comply with these instructions for use.
Neonatal Transport 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, Set Temp, Air Flow, or Audio Paused/Reset.
Screen images Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images.
A Letters in illustrations denote elements referred to in the text.
Trademarks Trademark
Trademark owner TM
Care-for-Me
Dräger
Globe-Trotter® Ferno®
Dräger
CaviCide®
Metrex Research Corporation
Ferno-Washington, Inc
Trademark Dismozon®pur EnerSys® Genesis®
Trademark owner Bode Chemie GmbH EnerSys and affiliates EnerSys and affiliates
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.
2
Instructions for Use TI500 Neonatal Transport Incubator
Definition of target groups For this product, users and service personnel 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, or maintain the medical device. The product must be used, installed, reprocessed, or maintained 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.
Instructions for Use TI500 Neonatal Transport Incubator
3
This page intentionally left blank
4
Instructions for Use TI500 Neonatal Transport Incubator
Contents
Contents Typographical conventions... Trademarks... Safety information definitions... Definition of target groups...
2 2 2 3
For your safety and that of your patients. . .
7
Product-specific safety information... 12 Application... 15 Intended use... 16 Environment of use... 16 Indications/contraindications... 16 Overview... 17 Front view... 18 Rear view... 19 Left side view... 20 Power chassis... 21 TI500 neonatal transport incubator overview . . 22 Abbreviations... 23 Symbols... 24 Technical definitions... 25 Operating concept... 27 TI500 controller... 28 Assembly and preparation... 31 Assembly safety information... 32 Unpackaging... 32 Connecting the battery... 33 Attaching the incubator to the trolley... 33 Installing the gas cylinders... 37 Installing accessories... 37 Getting started... 39 System start-up... 40 TI500 operational checkout procedure... 41 Operational checkout procedure for the trolley... 45
Instructions for Use TI500 Neonatal Transport Incubator
Operation...
47
Routine operation... Pre-warm... Auto-test... Setting the temperature... Infant placement... Placement of the skin temperature sensor . . . Humidity usage... Variable height adjustment of the trolley... Examination light operation... Power source usage... Infant transport... Accessory shelf usage... System shut-down...
48 49 49 50 50 51 52 52 54 54 54 55 56
Alarms...
57
Safety information... Alarm priority definitions... Alarm indication... Silencing alarms...
58 58 59 59
Problem solving...
61
Alarm messages... Other problems...
62 64
Cleaning and disinfection...
65
Safety information... 66 Disassembly... 67 Reprocessing procedures... 68 Reprocessing list... 71 Reassembly after cleaning... 73 Maintenance...
75
Overview... 76 Inspection... 77 Preventive maintenance... 78 Maintenance instructions... 80 Repair... 84 Disposal...
85
Disposal of the Medical Device...
86
5
Contents
Technical data... 87 TI500 system specifications... 88 EMC Declaration... 92 Recommended separation distances between portable and mobile RF communications equipment and the TI500 transport incubator... 98 List of accessories... 99 Accessories... 100
6
Instructions for Use TI500 Neonatal Transport Incubator
For your safety and that of your patients
For your safety and that of your patients General safety information... 8 Strictly follow these instructions for use... 8 Maintenance... 8 Safety checks... 8 Accessories... 8 Connected devices... 9 Not for use in areas of explosion hazard... 9 Safe connection with other electrical equipment... 9 Connection to other devices... 9 Functional safety... 10 Patient safety... 10 Patient monitoring... 10 Information on electromagnetic compatibility . . 11 Installing accessories... 11 Training... 11 Storing the instructions for use... 11 Restrictions for use... 11 Product-specific safety information... 12 Electrical precautions... 12 Explosion precautions... 12 EMC precautions... 13 Oxygen precautions... 13 System precautions... 14
Instructions for Use TI500 Neonatal Transport Incubator
7
For your safety and that of your patients
General safety information
Maintenance
The following WARNING and CAUTION statements apply to general operation of the medical device.
WARNING The medical device must be inspected and serviced regularly by professionals who possess the required qualifications due to their training and their experience. Repair of the medical device must also be performed by trained personnel with additional productspecific DrägerService training. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance".
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 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 16 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.
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.
8
Instructions for Use TI500 Neonatal Transport Incubator
For your safety and that of your patients
WARNING Risk of equipment damage and risk of injury
Safe connection with other electrical equipment
Reusing, reprocessing, or sterilizing disposable items can lead to a failure of the medical device and cause injury to the patient.
CAUTION Risk of patient injury
Do not reuse, reprocess, or sterilize disposable items. Disposable items were designed, tested, and manufactured for single-use only.
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.
WARNING Risk of equipment damage and risk of injury Do not use single-use packaged accessories if the package has been compromised.
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 may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations.
Not for use in areas of explosion hazard
Connection to other devices Device combinations approved by Dräger (see Instructions for Use of the individual devices) meet the requirements of the following standards: – IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance – IEC 60601-1-2:2007 Medical electrical equipment Collateral standard: electromagnetic compatibility, requirements and tests If Dräger devices are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the correct functioning of the devices may be compromised. The owner is responsible for ensuring that the resulting system meets the requirements of the applicable standards. Strictly observe Assembly Instructions and Instructions for Use for each networked device.
WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.
Instructions for Use TI500 Neonatal Transport Incubator
9
For your safety and that of your patients
Functional safety
Patient safety
The essential performance consists of:
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.
–
Air temperature regulation The air temperature setting (target value) is compared to the actual ambient air temperature and is regulated.
If any of the regulating actions are not possible, an alarm is generated. The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.
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:
WARNING
–
Risks that are obvious to users
Risk of malfunction
–
Unauthorized modifications to the medical device may lead to malfunctions.
Consequences of obvious improper use of the medical device
–
Potentially negative effects on patients with different underlying diseases
This medical device must not be modified without the permission of Dräger. WARNING Risk of reduced safety level
Medical device modification or misuse can be dangerous. CAUTION Risk of patient injury
Connecting electrical equipment to a power socket strip effectively leads to creating a medical electrical system. The result can be a reduced level of safety.
Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.
Comply with the requirements of IEC 60601-1 when constructing a medical electrical system.
Patient monitoring
WARNING Risk of malfunction
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.
Low battery charge can cause the system to shut down prematurely. Always verify the battery life at the recommended time periods listed in the battery maintenance section. Replace the battery if it either fails to meet the performance specification or meets the recommended replacement period.
10
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.
Instructions for Use TI500 Neonatal Transport Incubator
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: 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 92. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures.
Storing the instructions for use CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.
Restrictions for use CAUTION Device for use in health care 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.
Installing accessories CAUTION 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 system. Strictly observe assembly instructions and instructions for use.
Training Training for users is available from the Dräger organization responsible, see www.draeger.com.
Instructions for Use TI500 Neonatal Transport Incubator
11
For your safety and that of your patients
Product-specific safety information
Electrical precautions WARNING The potential for electrical shock exists with electrical equipment. Establish policies and procedures to educate your staff on the risks associated with electrical equipment. Noncompliance may result in death or serious injury. WARNING To ensure grounding reliability, plug the AC power cable only into a properly grounded (properly earthed), 3-wire hospital-grade or hospital-use socket. Do not use extension cables. If any doubt exists as to the grounding connection, do not operate the equipment. Noncompliance may result in death or serious injury. WARNING When any of the electronics covers are removed, an electrical shock hazard exists. Servicing should be performed by trained technical personnel. Noncompliance may result in death or serious injury. WARNING Do not reset a circuit breaker without assessing and correcting what caused the breaker or fuse to activate. Noncompliance may result in death or serious injury. WARNING Unplug the power cable from its power source before performing any service or cleaning the system. Noncompliance may result in death or serious injury.
12
WARNING Do not expose the device to excessive moisture. Personal injury or equipment damage could occur. Noncompliance may result in death or serious injury.
Explosion precautions WARNING The TI500 is not suitable for use in the presence of flammable anesthetic gases or other flammable materials, such as certain types of cleaning fluids. Noncompliance may result in death or serious injury. WARNING Before performing electrical service procedures or changing any battery, shut off the O2 cylinders. Noncompliance may result in death or serious injury. WARNING Before cleaning or maintenance, switch off all gas sources, and bleed off remaining pressure. When performing cleaning or maintenance procedures in an oxygen-enriched environment, a fire and explosion hazard exists. Noncompliance may result in death or serious injury. WARNING Small quantities of flammable agents (such as ethyls and alcohol) left in the incubator may cause a fire in connection with oxygen. This may result in death or serious injury.
Instructions for Use TI500 Neonatal Transport Incubator
For your safety and that of your patients
EMC precautions WARNING Use of accessories other than those listed and approved for use with this product, either as original or replacements items may result in increased emissions or decreased immunity of the equipment. Noncompliance may result in death or serious injury. WARNING The equipment should not be used adjacent to or stacked with other equipment unless verification of normal operation in the configuration in which it is to be used can be achieved. Noncompliance may result in death or serious injury.
Oxygen precautions WARNING Improper use of supplemental oxygen can cause serious side effects, including blindness, brain damage, and death. The risks vary with each infant. The attending physician prescribes the method, concentration, and duration of oxygen administration. Noncompliance may result in death or serious injury. WARNING The oxygen concentration inspired by an infant does not accurately determine the partial pressure of oxygen (PaO2) in the blood. The PaO2 should be measured by an accepted clinical technique when advised by the attending physician. Failure to do so could result in personal injury or equipment damage.
WARNING Oxygen administration may increase the noise level for the infant within the patient compartment. Noncompliance may result in death or serious injury. WARNING Oxygen flow rates cannot be used as an accurate indication of oxygen concentration in an incubator. Oxygen concentrations must be continuously monitored with a calibrated oxygen analyzer at intervals directed by the attending physician. If an oxygen analyzer is not part of the system, then the caregiver must provide an independent analyzer when oxygen is administered. Noncompliance may result in death or serious injury. WARNING Keep matches, lit cigarettes, and all other sources of ignition out of the area in which oxygen is in use. Textiles, oils, and other combustibles are easily ignited, and burn with great intensity in oxygen-enriched air. Prominently display “NO SMOKING” signs. Do not place auxiliary equipment that produces sparks within or near the incubator. Noncompliance may result in death or serious injury. WARNING On high-pressure O2 cylinders, use only approved reducing or regulating valves marked for oxygen service. Do not use these valves for air or gases other than oxygen since they could be hazardous when returned to oxygen service. Operate such equipment strictly according to the directions of the valve manufacturer. Noncompliance may result in death or serious injury.
WARNING If it is necessary to administer oxygen in an emergency, notify the attending physician immediately. Noncompliance may result in death or serious injury.
Instructions for Use TI500 Neonatal Transport Incubator
13
For your safety and that of your patients
WARNING Although oxygen-compatible materials are used in the oxygen delivery system, take special care when high-pressure oxygen, such as found in a medical O2 cylinder, is used. If their ignition temperature is reached, violent ignition of oil, grease, greasy substances, small particles or dust, dirt, or other particulate contaminants, even small particles of metal, could occur in the presence of high-pressure oxygen. If the O2 cylinder valve is opened too rapidly, an instantaneous increase in temperature could occur due to friction, particle acceleration, or adiabatic compression. This may result in death or serious injury. WARNING Keep oil, grease, greasy substances, dust, dirt, and other particulate contaminants away from oxygen regulators, cylinder valves, tubing, and all other oxygen equipment. Noncompliance may result in death or serious injury.
WARNING For infant safety, do not leave infant unattended when hand ports are open. The infant could fall which may result in death or serious injury. WARNING For infant safety, do not leave the access panels open longer than essential. The air temperature indicator does not accurately reflect the incubator temperature when the access panels are open. Under these conditions, the incubator temperature may be significantly lower than the displayed temperature. Noncompliance may result in death or serious injury. WARNING Perform the auto test sequence before each use to be certain that all control and alarm indicators are functional. Do not use if the test sequence does not perform as specified. Noncompliance may result in death or serious injury.
System precautions WARNING Incubator misuse may result in harm to an infant. Only properly trained personnel should use the incubator as directed by an appropriately qualified physician aware of currently known hazards and benefits. Noncompliance may result in death or serious injury. WARNING The incubator is equipped with a High Temperature alarm, but it is activated only by the air temperature. Thermal radiation from sunlight or other sources can cause temperature increase within the hood and can cause overheating of the infant without triggering the alarm. Do not permit extended exposure of the incubator to direct sunlight or other sources of thermal radiation. Noncompliance may result in death or serious injury.
14
WARNING Before using the optional trolley with variable height adjustment (VHA), read the Instructions for Use. Noncompliance may result in death or serious injury. WARNING To prevent inadvertent tip-over of the incubator during transport in the trolley's high position, do not exceed the 6.8 kg (15 lb) load limit of the optional accessory shelf. If only one oxygen cylinder is used, mount it in the compartment under the controller. Always push or pull the incubator forward or backward in a straight line along the length of the trolley (from the ends). Lateral or angular movement (across the width) can result in inadvertent tipover if the wheels encounter any obstacle. Noncompliance may result in death or serious injury.
Instructions for Use TI500 Neonatal Transport Incubator
Application
Application Intended use... 16 Environment of use... 16 Indications/contraindications... 16
Instructions for Use TI500 Neonatal Transport Incubator
15
Application
Intended use The TI500 neonatal transport incubator is intended for the transport of high risk, premature, low birth weight, or critically ill newborns. It provides a means to control air temperature, control oxygen,
and add relative humidity. The device is designed for use with patients weighing up to a maximum of 10 kg (22 lb).
Environment of use The TI500 neonatal transport incubator can be used in any department of the hospital that provides neonatal and infant care, including all levels of the Neonatal Intensive Care Unit (NICU), Special Baby
Care Unit, Step Down Nursery, Newborn Nursery, and Pediatrics. It can also be used in transport vehicles between hospitals.
Indications/contraindications The TI500 neonatal transport incubator is indicated for thermoregulation and controlling oxygen (optional) and humidity (optional). The TI500 neonatal transport incubator is not intended for home use.
16
Instructions for Use TI500 Neonatal Transport Incubator
Overview
Overview Front view... 18 Rear view... 19 Left side view... 20 Power chassis... 21 TI500 neonatal transport incubator overview... 22 Functional description... 22 Temperature control... 22 Abbreviations... 23 Symbols... 24 Technical definitions... 25
Instructions for Use TI500 Neonatal Transport Incubator
17
Overview
Front view
A
B
C
D
E
F G H
N I M L K
000
J
A Hood
I
Controller
B Accessory shelf (optional)
J
Trolley (optional) with variable height adjustment (VHA)
C Hand port D Hand port latch E Front access panel F Access panel locking knob G I.V. pole (optional)
K Gas cylinder holder L Gas cylinder retaining clamp M Guard rail N Hood latch
H Tubing grommet 18
Instructions for Use TI500 Neonatal Transport Incubator
Overview
Rear view
A
B
001
C
A Examination light B Air intake filter C Device type label
Instructions for Use TI500 Neonatal Transport Incubator
19
Overview
Left side view
B
A
C
F
E
D A Head-end access panel B Iris port C Access panel locking knob D Gas cylinder holder E Power chassis F Tubing grommets
20
Instructions for Use TI500 Neonatal Transport Incubator
002
0