Dräger Incubator 8000 IC Manuale utente
Operating InstructionsIncubator 8000 IC
Incubator 8000 IC
with ThermoMonitoring
Operating Instructions
1-505-94
Operating Instructions Incubator 8000 IC
NOTICE
Proprietary Information
This document contains information in which Dräger, Inc. claimed proprietary
rights. The information may not be reproduced in whole or in part except as
authorized in writing by Dräger. This information is the property of Dräger, Inc.,
it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService or its Authorized
Service Centers. Information about repairs can be obtained from Dräger or
Authorized Dealers. Dräger, Inc. will not be responsible for injury to persons or
damage to property arising directly or indirectly out of unauthorized repairs or
modifications to this device. Furthermore, any unauthorized repairs or modifica-
tions void any warranty extended by Dräger.
This document is provided for your information only. It will not be exchanged or updated
without request.
Trademarks
The Dräger name and logo are registered trademarks of Drägerwerk
Aktiengesellschaft.
Dräger, Inc. 1995
All rights reserved, Subject to modifications
Contents
3
Operating Instructions Incubator 8000 IC
Page
Checking Readiness for Operation 34
Before each Use 34
Checking Height Adjustment 34
Checking Hand Ports 35
Checking Front Door 35
Checking Air Filter 35
Testing Bed Tilt Mechanism 35
Activating Incubator Self Test 36
Checking Power Failure 36
Checking LEDs, Displays and Alarm 37
Operation 38
General Precautions During Patient Care 38
Starting Operation 42
Water Supply 42
Placing a Baby in the Incubator 42
Using Air Temperature Control 43
Using Skin Temperature Control 46
Thermo Monitoring, optional 52
Using Humidity Control 53
Using Oxygen 55
Care 60
Disassembly 60
Cleaning/Disinfecting/Sterilizing 62
Reassembly 63
Care for Humidification System 64
Before Reusing Incubator 64
Troubleshooting 66
Master Switch Module 66
Air Temperature Control Module 67
Skin Temperature Control Module 68
Oxygen Control 69
Humidity Control Module 70
Height Adjustment 71
Inspection and Maintenance 72
Replacement of Parts 72
Preventive Maintenance Intervalls 73
Technical Data 75
Ordering Information 77
Content Page
Introduction READ THIS FIRST 4
Operator's Responsibility for Patient Safety 4
Limitation of Liability 4
Warranty 5
Definitions 6
General WARNINGS and CAUTIONS 7
Precautions During Preparation 8
Precautions During Operation 8
Precautions During Care 10
Precautions During Maintenance 10
Intended Use 12
Description 13
Principle of Operation 13
Alarm Hierarchy 14
Ergonomics 14
Hygiene 14
What's What 16
Front View 16
Rear View 16
Control Panel 17
Main Module 17
Air Temperature Control Module 18
Skin Temperature Control Module 19
Oxygen Control 20
Humidity Control Module 21
Labels 22
Preparation 23
Before First Time Use 23
Front Flap 23
Quick Reference Flap 23
Hood 24
Open Double Walls 24
Mattress 24
Trendellenburg Position 25
Port Holes Doors 25
Repositioning Bed Endboard 25
Adjust Working Height 26
Open Rear Panel 26
Connect Sensor Module 27
Mounting Accessories 28
Instrument Tray 28
Mounting Plate 28
IV Pole 29
Additional Swivel Cabinet 30
Routing Cables and Hoses 31
Oxygen Therapy 32
Limitation of Liability
Dräger, Inc.'s liability, whether arising out of or related
to manufacture and sale of the goods, their installation,
demonstration, sales representation, use, performance,
or otherwise, including any liability based upon Dräger,
Inc.'s Product Warranty, is subject to and limited to the
exclusive terms and conditions as set forth, whether
based upon breach of warranty or any other cause of
action whatsoever, regardless of any fault attributable
to Dräger, Inc. and regardless of the form of action
(including, without limitation, breach of warranty,
negligence, strict liability, or otherwise).
THE STATED EXPRESSED WARRANTlES ARE IN
LlEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
WARRANTlES OF MERCHANTABILITY, FITNESS
FOR ANY PARTICULAR PURPOSE, OR
NONINFRINGEMENT.
Dräger, Inc. shall not be liable for, nor shall buyer be
entitled to recover any special incidental, or
consequential damages or for any liability incurred by
buyer to any third party in any way arising out of or
relating to the goods.
Introduction
Operator's Responsibility for Patient Safety
For correct and effective use of the product and in
order to avoid hazards, it is mandatory to carefully
read and to observe all portions of this manual.
The design of the equipment, the accompanying
literature, and the labeling on the equipment take into
consideration that the purchase and use of the
equipment are restricted to trained professionals, and
that certain inherent characteristics of the equipment
are known to the trained operator. Instructions,
warnings, and caution statements are limited, therefore,
largely to the specifics of the Dräger design. This
publication excludes references to various hazards
which are obvious to a medical professional and
operator of this equipment, to the consequences of
product misuse, and to potentially adverse effects in
patients with abnormal conditions. Product modification
or misuse can be dangerous. Dräger, Inc. disclaims all
liability for the consequences of product alterations or
modifications, as well as for the consequences which
might result from the combination of this product with
other products whether supplied by Dräger or by other
manufacturers if such a combination is not endorsed by
Dräger, Inc..
The operators of the incubator system must recognize
their responsibility for choosing appropriate safety
monitoring that supplies adequate information on equip-
ment performance and patient condition. Patient safety
may be achieved through a wide variety of different
means ranging from electronic surveillance of
equipment performance and patient condition to simple,
direct observation of clinical signs. The responsibility
for the selection of the best level of patient monitoring
lies solely with the equipment operator.
Introduction Operator's Responsibility for Patient Safety
Limitation of Liability
4
Operating Instructions Incubator 8000 IC
Application of this warranty is subject to the following
conditions:
1. Dräger, Inc. or its authorized representative must
be promptly notified, in writing, upon detection of
the defective material or equipment.
2. Defective material or equipment must be returned,
shipping prepaid, to Dräger or its authorized
representative.
3. Examination by Dräger or its authorized represen-
tive must confirm that the defect is covered by the
terms of this warranty.
4. Notification in writing, of defective material or
equipment must be received by Dräger or its
authorized representative no later than two (2)
weeks following expiration of this warranty.
In order to assure complete protection under this
warranty, the Customer Registration Card and/or
Periodic Manufacturer's Service Record (if applicable)
must be returned to Dräger within ten (10) days of
receipt of the equipment.
The above is the sole warranty provided by Dräger, Inc.
No other warranty expressed or implied is intended.
Representatives of Dräger are not authorized to modify
the terms of this warranty.
Dräger, Inc., Chantilly, VA
Warranty
All Dräger products are guaranteed to be free of de-
fects for a period of one year from date of delivery.
The following are exceptions to this warranty:
1. The defect shall be a result of workmanship or
material. Defects caused by misuse, mishandling,
tampering, or by modifications not authorized by
Dräger, Inc. or its representatives are not covered.
2. Rubber and plastic components and materials are
warranted to be free of defects at time of delivery.
3. Oxygen sensors capsules have a warranty up to the
expiration date printed on the sensor.
Any product which proves to be defective in
workmanship or material will be replaced, credited, or
repaired with Dräger, Inc. holding the option. Dräger, Inc.
is not responsible for deterioration, wear, or abuse.
In any case, Dräger, Inc. will not be liable beyond the
original selling price.
Warranty Introduction
5
Operating Instructions Incubator 8000 IC
Definitions
NOTE: A NOTE provides additional information
intended to avoid inconveniences during operation.
Inspection = examination of measured condition
Service = measures to maintain specified
condition
Repair = measures to restore specified
condition
Maintenance = inspection, service, and repair,
where necessary
Preventive = Maintenance measures at regular
Maintenance intervals
Typing conventions in this manual
LED display messages are printed in bold type,
e.g: SEt
CAUTION !
A CAUTION statement designates the possibility
of damage to equipment if disregarded.
WARNING !
A WARNING statement refers to conditions
with a possibility of personal injury if
disregarded.
Introduction Definitions
6
Operating Instructions Incubator 8000 IC
CAUTION !
Maintenance
In case of malfunction of this device, contact your
local DrägerService or our Factory Authorized
Technical Service Center.
The device must be inspected and serviced
(preventive maintenance) by factory authorized
technical service representatives at regular 2 year
intervals. A record must be kept on this
preventive maintenance. We recommend
obtaining a service contract through your vendor.
Maintenance or repair of the Incubator 8000 IC
shall be performed only by Dräger authorized
technical service representatives.
CAUTION !
Restriction of Distribution
Federal Law and Regulations in the United States
and Canada restrict this device to sale by or on
the order of a physician.
WARNING !
Do not use cellular or cordless phones within
33 feet (10 m ) of the equipment.
Wireless phones may cause malfunction in
electromedical equipment.
General WARNINGS and CAUTIONS
WARNING !
DANGER, risk of explosion if used in the
presence of flammable anesthetics.
This device is neither approved nor certified
for use in areas where combustible or
explosive gas mixtures are likely.
WARNING !
This device is to be used only in rooms with
line power installations complying with
national safety standards for hospital patient
rooms. (e.g., IEC 601.1, "Safety of Medical
Equipment).
To maintain grounding integrity, connect only
to a "hospital grade" receptacle. Always
disconnect supply before servicing.
WARNING !
Strictly follow this Operator's Instruction
Manual!
Any use of the product requires full
understanding and strict observation of all
portions of these instructions. The equipment
is only to be used for the purpose specified
under "Intended Use" (see page 12). Observe
all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the
equipment.
General WARNINGS and
CAUTIONS Introduction
7
Operating Instructions Incubator 8000 IC
WARNING !
Keep space above the incubator clear of
obstruction!
Nothing must be kept below the stroge
cabinets. Hoses, circuits, and cables must be
long enough for the height of the incubator
being adjusted. They must be routed in a way
that no kinking, disconnection or squeezing
can occure.
Precautions During Operation
Temperature
WARNING !
Do not cover phototherapy lights or incubator
hood with blankets, aluminum foil, or other
materials intended to boost the effect of
phototherapy. This could result in a build-up
of heat in the incubator. - Danger of
overheating patient!
WARNING !
Additional external heat sources, such as
sunlight, heat lamps, spot lamps, heated
pads, etc. should be avoided. They increase
air temperature inside the incubator in an
uncontrolled fashion.
WARNING !
Temperatures above 37 °C may only be used
on the order of a physician.
In this mode of operation, the baby´s
temperature must be monitored especially
carefully.
WARNING !
Always check baby's core temperature at
regular intervals!
WARNING !
Never leave baby unattended when front door
or hand ports are open to avoid any risk of a
patient falling out of the incubator.
Precautions During Preparation
Readiness for Operation
Load Limits for Storage Options
CAUTION !
Maximum load attached to rail must not exceed
25 kg (55 lbs).
WARNING !
The incubator is ready for operation only when
all checks have been performed successfully.
Introduction Precautions During Preparation
Precautions During Operation
8
Operating Instructions Incubator 8000 IC
Fire hazards associated with the use of oxygen
Physiological risks associated with the use of oxygen
Humidification System
WARNING !
Use only pure, distilled or demineralized
water. Do not add bactericidal agents.
WARNING !
Oxygen Concentration
The atmosphere inside the incubator should
only be enriched with oxygen by or on the
order of a physician or respiratory therapist.
It is absolutely essential that elevated oxygen
concentrations are selected on the basis of
arterially measured oxygen partial pressure in
the blood of the baby. This is the only way to
minimize the risk of both hyperoxemia, which
might cause, above all, retrolenta fibroplasia,
and hypoxemia which might contribute to
intraventricular hemorrhage and damage to
the baby's brain.
WARNING !
Fire Hazard!
Keep matches, lighted cigarettes, and all
other sources of ignition out of the room in
which the incubator is located. Textiles, oils,
and other combustibles are easily ignited and
burn with great intensity in an atmosphere
enriched with oxygen.
All oxygen valves, connections, and seals
must be kept free from oil and grease. - Open
valves slowly.
Do not use any electrical equipment inside the
incubator other than equipment and
instruments expressly designed and approved
for use in incubators.
Skin Temperature Control
WARNING !
Do not use skin temperature sensors to
rectally measure core temperature.
WARNING !
A displaced or detached skin temperature
sensor would be measuring air temperature
so that the baby could become overheated
(the temperature of the air in the incubator
would, however, not exceed 39 °C).
WARNING !
The sensor probe must never be placed under
the baby. It would be measuring and attempt-
ing to control core temperature rather than
skin temperature in this case.
WARNING !
Always verify that single use sensor probe is
specified and approved for use with Dräger
Series 8000 incubators.
WARNING !
Skin temperature control must not be used
with babies in shock. Because of reduced
peripheral bloodflow the skin temperature of
these babies occasionally lies below the core
body temperature. Using a skin temperature
control system could lead to overheating. We
recommend operating the incubator in air
temperature control mode when caring for
patients with such conditions.
Precautions During Operation Introduction
9
Operating Instructions Incubator 8000 IC
Precautions During Maintenance
CAUTION !
For disposal of batteries, follow all local, state,
and federal legislation with respect to
environmental protection.
WARNING !
Preventive Maintenance work on the Incubator
8000 IC may be performed by trained and
factory authorized staff only.
WARNING !
Treatment of batteries
- Do not throw into fire! risk of explosion
- Do not force open! cells contain
corrosive acid
WARNING !
Never operate the incubator if it has suffered
physical damage or does not seem to operate
properly. In this case always refer servicing to
properly trained and factory authorized service
personnel.
WARNING !
Always disconnect supply before servicing.
WARNING !
To avoid risk of infection, clean and disinfect
incubator and accessories before any
maintenance according to established hospital
procedures - this applies also when returning
units or parts for repair.
Precautions During Care
CAUTION !
Certain components of the incubator consist of
materials that are sensitive to certain organic
solvents sometimes used for cleaning and
disinfecting (e.g., alcohols, phenols, halogen
releasing compounds, oxygen releasing
compounds, strong organic acids, etc.). Exposure
to such substances may cause damage that is not
always immediately recognized. Do not sterilize
incubator and its components with ethylene oxide
(EtO) or by exposure to UV radiation (may cause
cracks in the PMMA (Plexiglas) parts!
WARNING !
Danger of burn injury
The exposed heater surface will still be very
hot after operation. It may take up to one hour
for the temperature to drop to 70 °C (158 °F)
with the incubator closed.
WARNING !
Always disconnect from power before
cleaning and disinfecting.
WARNING !
Always follow established hospital procedures
for handling equipment contaminated with
bodily fluids.
Introduction Precautions During Care
Precautions During
Maintenance
10
Operating Instructions Incubator 8000 IC
WARNING !
The oxygen cells contain an etching acid.
Do not destroy the capsule. Do not touch the
liquide if the capsule is leaking.
Call DrägerService if capsule is leaking and the
incubator is contaminated.
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