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Dräger caleo User manual

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WARNING
To properly use this medical device, read
and comply with these instructions for use.
Neonatal Incubator
Software 2.n
Instructions for Use
Caleo®
2
Operating Instructions Caleo, Software 2.n
NOTICE
Proprietary Information
This document contains information in which Dräger claims 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, it is provided
solely for the use intended.
Repairs/Modifications
Repairs on this device should be performed by DrägerService, its
Authorized Service Organizations or properly trained technicians.
Information about repairs can be obtained from Draeger or Authorized Service
Organizations. Dräger, its subsidiaries and affiliates are not responsible for injury
to persons or damage to property arising directly or indirectly from unauthorized
repairs or modifications to this device. Furthermore, any unauthorized repairs or
modifications could void any warranty extended by Dräger.
This document is provided for customer information only, and will not be
updated or exchanged without customer request.
Trademarks
The Dräger name and logo are registered trademarks of Dräger.
Caleo, Twincubator, Kangaroo Mode, and ThermoMonitoring are registered
trademarks of Dräger.
BabyLink, Caleo Calmcapsule, Caleo CleanSwitch, Caleo SoftBed,
Caleo JumboPorts, ThermoPad, and ThermoTrace are trademarks of Dräger.
© 2000 - 2012 Dräger Medical GmbH
All rights reserved, Subject to modifications
How to use these Operating Instructions
The headline ...
specifies the subject of the main chapter
to help you find your way around quickly.
The page body ...
contains instructions for use of the device
in a combination of text and illustrations. The information is
translated directly into sequences of activities showing the user
how to use the device.
The left-hand column ...
contains text
explaining the device and guiding the user directly to its uses
through concise, ergonomically arranged instructions.
zBullet points refer to individual actions.
1numbers refer both to illustrations and the sequence of
action when several steps are required to complete a task.
The right-hand column ...
contains illustrations
as a visual reference to the text, guiding the user to locate
parts of the unit itself. Elements mentioned in the text are
highlighted. Unnecessary details are omitted. Rendering of
screen displays guide the user and allow to reconfirm actions
performed.
147
Preparation
35
Installing Accessories
Moving the control unit to the opposite side
for 38 mm pole
1Loosen clamping screw to remove control unit. (Support
control unit to prevent it from dropping once clamping screw
is loosened.)
2Loosen clamping screw to remove holder.
Upon delivery, the control unit is attached to the 38 mm dia.
tube of 310 mm length (38/310 pole).
This tube is secured for transport with a screw attachment.
If required, the tube can be detached (recommendation: ask for
assistance from qualified technical personnel):
3Remove both caps from the tube. Insert a screwdriver into
the holes and release the tube.
To install control unit on the adjacent side:
lSlide holder over the other pole.
2Tighten clamping screw to fix holder in position.
lSet control unit to the desired working height
1Tighten clamping screw to secure control unit to the holder.
Mounting the control unit on the handle side
lInstall basic pole (2M 50 680), see page 37.
lScrew in the extension pole 38/600 (2M 50 691) or pole 38/
310 (2M 50 688).
lRe-install the control unit as specified in the Assembly
Instructions.
CAUTION !
When mounting control unit to its pole, ensure that there is
sufficient space to swivel the control unit.
(see "Tilting the bed", page 50).
CAUTION !
Only qualified technical personnel may move the control unit
from the wall side to handle side or vice versa.
CAUTION !
Do not remove cable to the control unit from the cable guides
on the basic pole.
Make sure there is sufficient space to swivel and tilt the unit.
02470
2
1
3
256
4
Operating Instructions Caleo, Software 2.n
This page intentionally left blank
Operating Instructions Caleo, Software 2.n
5
5
Contents
Important Safety Information 7
Intended Use 19
What’s What 21
Operating Concept 29
Preparation 31
Checking Readiness For Operation 54
Operation 59
Care 117
Maintenance 136
Maintenance intervals 136
Troubleshooting 141
Theory of Operation 149
Glossary 163
Technical Data 165
Ordering Information 171
6
Operating Instructions Caleo, Software 2.n
This page intentionally left blank
7
Operating Instructions Caleo, Software 2.n
Important Safety Information — Intended Use
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Summary of WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Restrictions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Important Safety Information
8
Operating Instructions Caleo, Software 2.n
Operator's Responsibility for Patient Safety
Definitions
Important Safety Information
Operator's Responsibility for Patient Safety
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. Draeger
disclaims all liability for the consequences of product alter-
ations 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 manufac-
turers if such a combination is not endorsed by Dräger.
Patient monitoring
The operators of this infant incubator system must recognize
their responsibility for choosing appropriate safety monitoring
that supplies adequate information on equipment 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. Responsibility for
the selection of the best level of patient monitoring lies solely
with the equipment operator.
Distributed in the USA by:
3135 Quarry Road, Telford PA 18969
WARNING !
Strictly follow these Instructions for Use
Any use of the product requires full understanding and
strict observation of all portions of these instructions.
This equipment is only to be used for the purpose
specified under "Intended Use" (see page 19).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
Definitions
NOTE: A NOTE provides additional information intended to
avoid inconveniences during operation.
Definition of target groups
Users, maintenance personnel and professionals are defined
as the target groups for this medicine device.
These target groups were trained to handle the medical device
and have the necessary specialized knowledge and training,
the necessary know how to use, install, prepare, maintain or
repair the medical device.
Dräger points out that only the defined target groups should
use, install, prepare, maintain or repair the medical device.
User
Users are persons who may use the medical device in accor-
dance with its intended purpose.
Maintenance personnel
Maintenance personnel are persons who are responsible to the
owner or operator for the maintenance of the medical device.
Maintenance personnel are persons who install, prepare or
maintain the medical device in working condition.
Professionals
Professionals are persons who may perform repair jobs or
complex maintenance jobs on the medical device.
Typing conventions in this manual
Display messages are printed as »message«, e. g:
»confirm new mode with rotary knob«
Controller keys are designated as »Key Name«, e.g. »man.«
indicates a reference to the operating manual on the
incubator, e.g. for a control element.
Symbols
Please refer to "Glossary" on page 163 for explanations.
Labels on the equipment
Please refer to "Labels" on page 25.
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 equipment or other property.
Important Safety Information
9
Operating Instructions Caleo, Software 2.n
Summary of WARNINGS and CAUTIONS
Summary of WARNINGS and CAUTIONS
WARNING !
Strictly follow these Instructions for Use
Any use of the product requires full understanding and
strict observation of all portions of these instructions.
This equipment is only to be used for the purpose
specified under "Intended Use" (see page 19).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
WARNING !
This device may only be used by properly trained
personnel under the supervision of qualified medical
personnel familiar with the currently known risks and
benefits of using an infant incubator.
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Caleo
incubator system.
Only use accessories that are qualified to the required
specifications for an intended use in an oxygen enriched
environment.
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/EN 60601-1 "Medical
Electrical Equipment - General Requirements For
Safety").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
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 !
The use of this device requires continuous supervision
of the infant by trained nursing personnel in order to
ensure immediate corrective action in situations with a
risk of patient injury.
CAUTION !
Restriction of Distribution
Federal Law (U.S.) restricts this device to sale by or on the
order of a physician.
CAUTION !
Device for use in health care facilities only and exclusively by
persons with specific training and experience in its use.
CAUTION !
Maintenance
The device must be inspected and serviced at regular 1 year
intervals. A record must be kept on this preventive
maintenance. We recommend obtaining a service contract
with DrägerService.
For repairs of the Caleo incubators we recommend that you
contact DrägerService.
Important Safety Information
10
Operating Instructions Caleo, Software 2.n
Precautions During Preparation
WARNING !
Always observe all precautions against fire hazards from
oxygen (see page 61).
WARNING !
Never leave infant unattended when access doors or
access ports are open to avoid any risk of an infant
falling out of an incubator.
WARNING !
Always ensure that access port catches are securely
engaged in order to avoid any risk of an infant falling out
of an incubator.
WARNING !
When opening and closing front door, avoid pinching or
jamming hoses and cables in the attached double wall.
WARNING !
Always ensure that both knobs of the large access doors
are engaged in position in order to avoid any risk of an
infant falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
The attached double wall must be positioned parallel to
the front door otherwise the ducted flow of warm air will
be interrupted!
WARNING !
When opening and closing side doors, avoid pinching or
jamming hoses and cables in the attached double wall.
WARNING !
Always ensure that both knobs of the side doors are
engaged in position in order to avoid any risk of an infant
falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
Always observe the maximum load of the infant bed
(5 kg, 11 lbs).
WARNING !
Never leave infant unattended when the bed has been
pulled out to avoid any risk of an infant falling out of an
incubator.
WARNING !
Do not lean on the bed when it is pulled out. Equipment
damage with risk of patient injury may result.
WARNING !
Always ensure that the bed is pushed all the way in!
Otherwise the ducted flow of warm air will be interrupted,
and the infant may be warmed or cooled excessively.
WARNING !
Do not use the X-ray drawer as a writing support or as a
bed for the infant. Risk of equipment damage or patient
injury.
WARNING !
Always ensure that the x-ray drawer is pushed all the
way in! Otherwise the ducted flow of warm air will be
interrupted, and the infant may be warmed or cooled
excessively.
WARNING !
Make sure that the installed hoses are routed freely and
safely.
WARNING !
Do not reach between incubator housing and housing
support while tilting the bassinet. Risk of injury!