Drager Babytherm 8000 LDR User manual

Babytherm® 8000 LDR

Warming Bed

Instructions for Use

NOTICE

Proprietary Information

This document contains information in which Dräger 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; it is provided solely for the use intended.

Repairs/Modifications

Repairs on this device shall be performed only by DrägerService, a division of North American Dräger (NAD), or its Authorized Service Centers. Information about repairs can be obtained from Dräger or Authorized Dealers. NAD or Dräger 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 modifications 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 and the name Babytherm® are registered trademarks of Dräger Medizintechnik GmbH.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Operator's Responsibility for Infant Safety . . . . . . . . . . . . . . . . . 1

Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Definitions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

General WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . 5

Precautions During Preparation . . . . . . . . . . . . . . . . . . . . . . . . . 6

Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Precautions During Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Precautions During Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 7

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Mattress Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Storage of Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Installing Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Opening Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Installing Canopy (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Selecting a Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Tilting the Bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Tests of Readiness for Operation . . . . . . . . . . . . . . . . . . . . . . . . 13

Preuse Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 13

General Precautions During Infant Care . . . . . . . . . . . . . . . . . 14

Heat Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Heater Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Mattress Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Mattress Heater Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . 16

Mattress Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Control Systems Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Control Systems Operator Test . . . . . . . . . . . . . . . . . . . . . . 20

Heater Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Operation without Concurrent Use of a Radiant Warmer . . . . 22

Oxygen Therapy with Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Adjusting Mattress Temperature . . . . . . . . . . . . . . . . . . . . . . . 23

Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Power-Down Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Using the Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Operation with Concurrent Use of a Radiant Warmer . . . . . . . 31

Cleaning/Disinfecting/Sterilizing . . . . . . . . . . . . . . . . . . . . .33

Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Cleaning and Disinfection Procedures . . . . . . . . . . . . . . . . . . . . 33

Before Next Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

iii

Contents

Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .35

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Repair and Replacement of Parts . . . . . . . . . . . . . . . . . . . . 35

Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . 35

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Mattress Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Warning - Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Danger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Operator's Responsibility for Infant Safety

For correct and effective use of the product and in order to minimize 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 infants with abnormal conditions. Product modification or misuse can be dangerous. Dräger 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.

Introduction

The operators of the heated bassinet system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and infant condition. Infant safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and infant condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of infant monitoring lies solely with the equipment user.

Limitation of Liability

Dräger'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'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 and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise).

Introduction

Dräger 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.

Limited Warranty

All Dräger products are guaranteed to be free of defects in material and workmanship for a period of one year from date of delivery.

The following are exceptions to this warranty:

1. Defects caused by misuse, mishandling, tampering, or by modifications

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.

not authorized by Dräger or its representatives are not covered.

2. All consumable and disposable products are guaranteed to be free from defects upon shipment only.

Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired with Dräger holding the option. Dräger is not responsible for deterioration, wear, or abuse. In any case, Dräger will not be liable beyond the original selling price.

This warranty is rendered void and Dräger shall not be held liable for condition as resultant from:

1. Damage to the unit is incurred as a result of mishandling.

2. The customer fails to maintain the unit in a proper manner.

3. The customer uses any parts, accessories or fittings not specified or sold by Dräger.

4. Sale or service is not performed by an authorized service/dealer.

Application of this warranty is subject to the following conditions:

1. Dräger or its authorized representative must be promptly notified, in writing, upon detection of the defective material or equipment.

2. Contact Dräger Customer Service at 1-800-4DRAGER for a Return Authorization Number.

3. Defective material or equipment must be returned, shipping prepaid, to Dräger or its authorized representative.

4. Examination by Dräger or its authorized representative must confirm that the defect is covered by the terms of this warranty.

Introduction

5. 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.

The above is the sole warranty provided by Dräger. No other warranty expressed or implied is intended. Representatives of Dräger are not authorized to modify the terms of this warranty.

Dräger, Telford, PA

Introduction

Definitions and Symbols

Warnings

Cautions

Notes

Terminology

A WARNING statement refers to conditions with a possibility of personal injury or death if disregarded.

A CAUTION statement designates the possibility of damage to equipment or improper operation if disregarded.

A NOTE provides additional information intended to clarify apparently contradictory or confusing situations.

Inspection examination of actual condition

Service measures to maintain specified condition

Repair measures to restore specified condition

Maintenance inspection, service, and repair, where

necessary

Preventive Maintenance

Maintenance measures at regular intervals

Typing conventions in this manual:

LED messages are printed in bold type:

Symbols

Example:

CAUTION

ATTENTION

SEt

Refer to accompanying documents before operatin

Consulter l es documents ci -joints avant de faire fonctionner l’appareil.

Denotes IEC601-1 type of applied part.

Protective earth symbol.

equipment.

General WARNINGS and CAUTIONS

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." Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment.

Warning: This device is to be used only in rooms with line power

installations complying with national safety standards for hospital infant rooms. To maintain grounding integrity, connect only to a "hospital grade" receptacle. Always disconnect power before servicing.

Warning: Do not use in the presence of flammable anesthetics. Turn off

and disconnect oxygen supply when performing cleaning and service. Keep matches, lighted cigarettes, and all other sources of ignition out of the room in which the Babytherm is located. Small quantities of flammable agents, such as ethyls and alcohol, can cause a fire in connection with oxygen left in the Babytherm in the presence of ignition sources.

Introduction

Warning: Do not use cellular phones or similar wireless communication

equipment within 33 feet (10 m) of the Babytherm 8000 LDR. Wireless phones may cause malfunction in electromedical equipment.

Caution: Restriction of Distribution

: Federal Law restricts this device

to sale by or on the order of a physician.

Caution: Maintenance

your local DrägerService

: In case of malfunction of this device, contact

technician or our Factory Authorized Technical Service Center. The device must be inspected by competent and factory authorized technical service representatives at regular intervals. A record must be kept on this preventive maintenance. Maintenance or repair of the Babytherm 8000 LDR shall be performed only by Dräger authorized technical service representatives.

Warning: Never operate the heated bassinet 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.

Introduction

Precautions During Preparation

Warning: Use of gel mattress when mattress heater is switched off will

result in infant becoming hypothermic. Use foam rubber mattress when mattress heater is not in use for extended periods (> 15 min.).

Caution: Never route infant circuits or lines over top of panels – they

may get pinched when folding up panels or when installing cover.

Precautions During Operation

Warning: To prevent infant fall, do not leave infant unattended when

any panels are down. All panels must be erect and secure during transport to prevent infant fall.

Warning: When folding up surrounding panels, take care not to pinch

infant body parts, circuits, or other items, such as sheets.

Warning: Temperature Monitoring

skin condition at regular intervals and adjust temperature setting to individual infant needs. Infant temperature must be monitored particularly carefully during phototherapy or while a radiant warmer is used in conjunction with the Babytherm heated bassinet.

Warning: Mattress Heater

mattress must be placed directly on the heated tray surface. Always take into account warm-up time of the mattress (approximately 1 hour) before placing an infant in the bassinet.

Warning: To minimize infant overheating, always consider effect of

additional heat sources, such as phototherapy lamps or radiant warmers. They increase the heat directed to the infant. Avoid direct sunlight.

Warning: Do not obstruct conductive heat transfer by placing

additional blankets or other insulating covers underneath the infant.

Warning: Set temperatures in the lower extended temperature range

only on the order of a physician. Check the infant's temperature and skin condition at regular intervals.

: When mattress heating is used, the gel

: Check the infant’s temperature and

Warning: Check the infant's temperature and skin condition at regular

intervals.

Introduction

Warning: Always use a proper fitting thin sheet (Part No. 2M21272).

Do not fold the sheet under the gel mattress more than 3". To prevent infant fall in Trendelenberg or reverse Trendelenberg position always use proper fitting mattress sheet.

Warning: When used with an infant radiant warmer, check its

operator’s manual for directions of the correct heat level and distance to the infant.

Warning: Use of radiant warmers may increase insensible water loss.

Measures to maintain desired fluid levels should be considered.

Warning: Use of Radiant Warmer

recommended. Dräger cannot warrant or endorse the safe performance of third party radiant warmers for use with the Babytherm 8000 LDR. Specifically, combinations with radiant warmers that are not intended for use with heated bassinets bear risks of excessive overall heat transfer to the infant.

Caution: Remove from mattress all objects with sharp edges. Do not

fold gel mattress. The gel mattress may become damaged.

Precautions During Care

Warning: Always follow accepted hospital procedures for handling

equipment contaminated with body fluids.

Warning: Always disconnect AC line cord before cleaning and

disinfecting.

Caution: Do not launder mattress in an automatic washing machine.

Do not autoclave mattress.

Precautions During Maintenance

Warning: To minimize the risk of infection, clean and disinfect bassinet

and accessories before any maintenance according to established hospital procedures – this applies also when returning units or parts for repair.

: Use of the Dräger RH600 warmer is

Warning: Maintenance work on the Babytherm 8000 LDR may be

performed by trained and factory authorized staff only.

Warning: Never operate the heated bassinet 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.

Introduction

Intended Use

Babytherm 8000 LDR is a heated bassinet intended as a therapeutic device providing warmth, with or without the use of a canopy, for premature and full-term neonates and infants up to 16 lbs.

Mattress Heating

The Babytherm 8000 LDR features a mattress heating system that uses conductive heat to warm up infants and to keep them warm.

The system consists of a gel mattress, a heating plate and an electronic control and monitoring unit. The gel is enclosed by a soft, skin compatible film.

The mattress molds itself to the body contours of the infant lying on it, resulting in a large contact surface, a property that helps promote thermal heat transfer to the infant and minimizes pressure points. A cold gel mattress, on the other hand, dissipates infant thermal energy. The gel material has an excellent capacity for storing heat. When the power supply is disconnected (e. g. during transport within the hospital), the infant is kept warm for approximately 15 minutes if sufficiently insulated (blanket, cover).

Description

Features

The heating plate consists of an aluminum plate with a heater element attached to its under side. It distributes heat evenly over the entire bed area.

The control and monitoring unit is located under the heating plate and faces the side most frequently accessed by caregivers.

The micro-processor controlled system continuously monitors the status of the electronic temperature control and alarm system, and alerts the user if any faults are detected.

With its ergonomic design including:

• foldable side panels for increased access to the infant

• tilting bed for Trendelenberg and reverse Trendelenberg position

• pop-up side table – integrated hand rail

• cable management system

• storage space in the cabinet

• 5 inch diameter castors, two with locks

• optional canopy

it serves an important function for newborn babies from the first minute after birth until discharge to home.

+ 35 hidden pages