HEATED BOWL HOLDER 4904.xxxx Operating Instructions Ver 03 May 2007

Copyright notice All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws. © Copyright MAQUET GmbH & Co. KG Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development. V03.01.02.22-05-2007

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

Table of contents

1 1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.3.1 1.2.3.2 1.3 1.3.1 1.3.1.1 1.3.1.2 1.3.1.3 1.3.2 1.3.2.1 1.3.2.2 1.3.3 1.4 1.4.1 1.4.1.1 1.4.1.2 1.4.2 1.4.3 1.4.4

Introduction Foreword... 1 Environment protection... 1 Packaging... 1 MAQUET products... 1 Disposal... 1 Within the European Trade Area... 1 Outside the European Trade Area... 1 How to use these operating instructions... 2 Symbols... 2 Actions and responses... 2 Cross-references... 2 Order number... 2 Definitions... 3 Definition of safety notes... 3 Definition of other notes... 3 Graphic symbols used... 4 Heated bowl holder... 5 Pictoral guide... 5 Description... 6 Safety equipment... 6 General safety notes... 7 Applicable standards... 7 Proper use... 8

2

Summary of safety notes

3 3.1 3.1.1 3.1.2 3.2 3.3 3.3.1 3.3.2 3.4 3.4.1 3.4.2

Use Putting into service... 12 Storage... 12 Shipping and unpacking... 12 Potential equalisation... 13 Heating... 13 Switch on bowl holder... 13 Set the temperature... 14 Stand and wheeled base... 17 Adjust the height... 17 Move the bowl holder... 18

4 4.1 4.2

Cleaning, disinfection and sterilisation Cleaning and disinfection... 19 Sterilisation... 20

5 5.1 5.2 5.2.1 5.2.2 5.2.3

Maintenance and repairs Maintenance... 21 Repairs... 21 Replacing fuses... 21 Bimetallic fuse... 22 Inspections... 22

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

I

Table of contents

6

Technical specifications

7 7.1 7.2

Accessories Clamping ring... 24 Bowl... 25

instructions Heated bowl holder 4904.9500/9600 II Operating GA 4904.95 EN 03

Introduction Foreword

1

Introduction

1.1

Foreword Your facility has selected the leading-edge medical technology made by MAQUET. We sincerely appreciate the trust you have placed in us. MAQUET is a member of the GETINGE group which is consistently directing its attention to pioneering medico-technical solutions.

1.2

Environment protection

1.2.1

Packaging

1

MAQUET is one of the world’s leading suppliers for emergency rooms, operating rooms and intensive care units. MAQUET has been standing for innovation and advance in medical technology ever since it was founded in 1838. Solutions relevant to the needs of practice and customer-oriented services optimize working cycles and boost economy in hospitals – all to the benefit of the patient.

The packaging is made of materials compatible with the environment. MAQUET will dispose of the packaging materials upon request. 1.2.2

MAQUET products MAQUET will take back used products or those which are no longer in service.

1.2.3

Disposal

1.2.3.1

Within the European Trade Area This product is governed by the 2002/96/EC Directive (Directive on Waste Electrical and Electronic Equipment). This product has not been registered for use in private households; disposal using municipal

1.2.3.2

Please contact your MAQUET factory representative for more detailed information.

collection points for used electrical equipment is not authorized. Please contact your MAQUET factory representative for more detailed information on correct and legal disposal.

Outside the European Trade Area When disposing of this product, be sure to comply with the applicable national regulations on the treatment and disposal of used equipment.

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

1

1

Introduction How to use these operating instructions

1.3

How to use these operating instructions In this section you will find information on how these operating instructions are arranged and explanations on the signs and symbols used here. These operating instructions include information on the use of the heated bowl holder. Our products are the subject of continuous improvement; consequently this manual will not reflect design changes undertaken after the

1.3.1

Symbols

1.3.1.1

Actions and responses The "⌧" symbol identifies an action taken by the user while the " " symbol identifies the reaction which this will induce in the system.

1.3.1.2

Cross-references References to other pages in these Operating Instructions are identified with a double arrow symbol "".

1.3.1.3

Order number An "X" in the order number (e.g. 1122.33X4) is a placeholder for a number of variants.

instructions Heated bowl holder 4904.9500/9600 2 Operating GA 4904.95 EN 03

publication date. Please contact our customer service department if you have questions. These operating instructions are to be read and applied by every person who uses or operates the heated bowl holder. To be observed in addition to these operating instructions and local accident prevention regulations are the recognised rules for safe and professional work.

Example: ⌧ Turn on the light switch. Lamp lights up.

Introduction How to use these operating instructions

1.3.2

Definitions

1.3.2.1

Definition of safety notes

1

A safety note is composed of several components: • A pictogram, • A descriptor which indicates the degree of hazard, • Information on the nature of the hazard, and • Information on how to avoid the hazard. Pictogram

Descriptor

Hazard

Consequences

Hazard

This symbol identifies This symbol identifies a disituations which could result in rect and immediate risk to personal injury. persons which could result in grave injury or a fatality.

Warning

This symbol identifies a potentially dangerous situation.

Minor injury hazard.

Caution

This symbol identifies warnings.

Hazard of damage to the unit or other property.

Fig. 1: Definition of safety notes

1.3.2.2

Definition of other notes Notes not referring to personal injury or property damage will be used as follows: Pictogram

Descriptor

Reference to

Note

Supplementary assistance or further useful information.

Fig. 2: Definition of other notes

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

3

1 1.3.3

Introduction How to use these operating instructions

Graphic symbols used Symbols

Meaning Labelling in compliance with the IEC 60601-1 standard. Symbol for "Potential equalization".

Labelling of Category AP equipment as per the IEC 60601-1 standard. Explosion protection by avoiding sources of ignition when using flammable blends of anaesthetics which are mixed with air, oxygen or nitrous oxide. Labelling for devices incorporating a Type B applied part as defined in the IEC 60601-1 standard. Degree of protection against electric shock. Labelling for Class I products, developed and marketed in compliance with Medical Device Directive 93/42/EEC.

Labelling in compliance with the EN 980 standard. Symbol for "Manufacturing date".

Labelling in compliance with the IEC 60601-1 standard. Symbol for "Observe the accompanying documents".

Identification of Category AP equipment as per the IEC 60601-1 standard.

Transportation label. Symbol for "Temperature limitations".

Transportation label. Symbol for "Relative humidity".

Transportation label. Symbol for "Atmospheric pressure".

Labelling as per the 2002/96/EC Directive (Directive on Waste Electrical and Electronic Equipment). Symbol for "Do not dispose of at the municipal collection points for used electrical equipment". Fig. 3: Symbols

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Introduction Heated bowl holder

1.4

Heated bowl holder

1.4.1

Pictoral guide

1

1

2

7

8 3

9

4 5

6 10

Fig. 4: Pictoral guide, bowl holder 1 4001.5900 Bowl (removable) 2 4001.6000 Clamping ring 3 Control panel 4 Potential equalisation 5 Handle screw

6 Trolley 7 Protective shield 8 Grab ring 9 Mains cord 10 Closure cap

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

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1

Introduction Heated bowl holder

1.4.1.1

Description The bowl holder is heatable. It is used to heat solutions of physiological table salt, for invasive flushing of the abdominal cavity or to moisten and heat compresses during operations. The bowl heater is installed in a cylindrical stainless steel housing. This cylindrical stainless steel housing is concealed by the heating plate at the top. At the lower cover there is an attachment flange for

1.4.1.2

the stand and the hole through which the mains cord passes. A holding ring is also attached to the stainless steel housing. The regulation electronics are located in the cylindrical stainless steel housing. The heated bowl holder is extremely long-lived. When used properly the heated bowl holder may achieve a service life in excess of 10 years.

Safety equipment The heated bowl holder is equipped with five tandem swivel castors; three of these castors are electrically conductive. Located below the housing are two 2.5 A fuses to protect the heating element. A bimetallic safety thermostat limits the temperature at the heating plate to 150 °C. Once this safety thermostat has been tripped, the heated bowl holder can be reactivated by turning the main switch off and back on again. To provide additional protection against overheating, e.g. in case the temperature regulator should fail, a supplementary safety thermostat will switch the unit off completely when the tem-

instructions Heated bowl holder 4904.9500/9600 6 Operating GA 4904.95 EN 03

perature reaches about 200 °C. After such an incident the heated bowl holder may be returned to operation only by an authorised service technician. The heated bowl holder will switch off in the event of excess temperature, short circuit or sensor failure. The heating will also switch off automatically if there is no bowl on the heating plate. The LEDs in the thermometer system will then all blink simultaneously. The mobile holder is equipped with a grab ring to prevent burns when moving the holder. A protective shield also prevents unintentional contact with the heating plate.

1

Introduction Heated bowl holder

1.4.2

General safety notes The heated bowl holder has been built in accordance with the state of the art and recognised safety rules. In spite of this, using this device may involve hazard to life and limb for the user or third parties and damage to the heated bowl holder and other property.

rules on accident prevention and environment protection.

Use the heated bowl holder only if it is in perfect working order; use it only in accordance with the intended purpose, being aware of safety issues and hazards, and adhering to the operating instructions. Be sure to have any defects, and in particular those which could impact safety, repaired at once.

Replacment parts shall comply with the specifications set forth by the manufacturer. This is always guaranteed if you use original-equipment spares.

Do not modify the heated bowl holder in any way without the manufacturer's permission to do so.

Always store the operating instructions near the use point for the heated bowl holder for ready reference.

Always have recurring maintenance and inspections carried out at the prescribed intervals or as specified in the instruction manual. Ensure that operating and auxiliary materials and spare parts are disposed of in compliance with environment protection regulations.

Observe, in addition to the operating instructions, all legal regulations and other binding 1.4.3

Applicable standards The heated bowl holder complies with the following standards: • EN 60601-1:1990 and A1:1993 and A2:1995 • EN 60601-1-2 • VDE 0107 • VDE 750, Part 206

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

7

1 1.4.4

Introduction Heated bowl holder

Proper use The heated bowl holder is used exclusively to heat solutions of physiological table salt, for invasive flushing of the abdominal cavity or to moisten and heat compresses during opera-

tions. Any other use or use beyond these specifications is deemed not to be in accordance with the intended purpose.

The heated bowl holder may not be used: • To store, clean or warm instruments, objects and other substances • To store, clean or warm up organic substances such as organs, parts of organs, body tissue, blood or foods • To store or warm up medications containing an active ingredient mentioned in the 65/65/EEC Directive • If residues or cleaning agents or other contaminants are present

The uses listed here are deemed not to be in accordance with the purpose for which this device was intended. The manufacturer shall bear no liability for any injury or damage resulting from such misuse. The user bears sole risk. Use in accordance with the intended purpose also includes observing the instructions in this manual and adhering to the inspection and maintenance terms.

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Distinction is made as follows: • 4904.9500 Heated bowl holder with European standard plug • 4904.9600 Heated bowl holder with Swiss standard plug

Summary of safety notes Heated bowl holder

2

2

Summary of safety notes DANGER! The temperature indication may be skewed if the original-equipment bowl is not used. The temperature of the solution may then be considerably above or below the value shown and thus can give rise to a life-threatening situation for the patient. Use only the original-equipment bowl.

DANGER! Residues and grime at the bowl can be a source of infection. Clean the bowl particularly thoroughly.

DANGER! If less than 1 litre is present in the bowl a higher temperature than that set at the thermostat might be attained; this could result in a life-threatening situation for the patient. The amount of liquid in the bowl may be no less than 1 litre.

DANGER! Where there are small quantities (1 to 2 l) of liquid in the bowl, the current temperature may overshoot the set-point temperature. The current temperature is then above the set-point temperature; the LED labelled "ÜBER" lights. In this case wait until the temperature drops and the LED labelled "OK" lights.

WARNING! Poor heat transfer and temperature regulation will result if the heating plate or the temperature sensor is soiled or if there are objects or drapes between the heating plate and the bottom of the bowl. Thus it is necessary to ensure that the heating plate and temperature sensor are clean and that there are no objects between the heating plate and the bottom of the bowl.

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

9

2

Summary of safety notes Heated bowl holder

WARNING! The temperature distribution may not be uniform where a larger volume of liquid is present. That is why it is important to stir the liquid before it is used.

WARNING! The heating plate remains hot after the bowl has been removed. This can cause burns. Do not touch the hot heating plate.

WARNING! The heating plate will be hot during operation. If you wish to adjust the height or move the unit, then grasp the bowl holder only at the grab ring in order to avoid burns.

WARNING! Cords can cause falls if laid where people will walk. Do not lay cords across areas where people will walk.

WARNING! The heated bowl holder can tip over during movement if the upper section is extended. That makes it necessary to lower the upper section before moving the bowl holder (see the label on the bowl holder).

WARNING! The heated bowl holder can tip over during movement if the castors roll over the mains cord or other objects. That is why you should never roll the bowl holder over objects on the floor.

CAUTION! Pulling on the cord to disconnect the plug from the wall socket could cause the conductors to become detached from their contacts. Never pull on the cord; always grasp the plug itself when detaching it from the wall socket in order to disconnect the heated bowl holder from the power supply.

CAUTION! Soiled heating plates and temperature sensors will not work properly. Ensure that the heating plate and the temperature sensor at the centre of the heating plate are always clean.

CAUTION! Steam cleaning equipment would damage the temperature sensor. Do not use a steam cleaning unit for cleaning purposes.

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Summary of safety notes Heated bowl holder

2

CAUTION! Chlorine and compounds liberating chlorine will cause stainless steel to rust. Never use any such agents for disinfection purposes.

CAUTION! Alcohol can damage the surfaces of plastic components. That is why no agents or disinfectant sprays containing alcohol should be used.

CAUTION! Residues of cleaning agents and other soiling can result in corrosion. Ensure that no residues or grime remain in the bowl holder.

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

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3

Use Putting into service

3

Use

3.1

Putting into service

3.1.1

Storage The heated bowl holder, when packed, may be exposed to the ambient conditions within the following limits for 15 weeks: Ambient temperature Relative humidity Atmospheric pressure

3.1.2

-20 °C to +50 °C 10% – 95% 500 hPa to 1060 hPa

Shipping and unpacking The heated bowl holders are packed ready for shipping at the factory. When shipping at a later point in time, it is advisable to set the unit in the same setting and to use appropriate packaging. If at all possible, use the original packing material to move the heated bowl holder to its final

instructions Heated bowl holder 4904.9500/9600 12 Operating GA 4904.95 EN 03

location. Check the condition of the heated bowl holder. Report any shipping damage immediately. Please contact the manufacturer or the branch office serving your location. You will find the address on the last page of this manual.

Use Potential equalisation

3.2

3

Potential equalisation The heated bowl holder is provided with potential equalisation. You will find the potential equalisation plug at the attachment flange for the holder.

DANGER! Electrostatic charges can endanger the patient. Electrostatic charges are dissipated by way of potential equalisation. Always connect the potential equalisation plug with a ground contact before using the heated bowl holder. If you wish to use the heated bowl holder, then attach the potential equalisation plug to a grounding contact beforehand. 3.3

Heating

3.3.1

Switch on bowl holder

CAUTION! Pulling on the cord to disconnect the plug from the wall socket could cause the conductors to become detached from their contacts. Never pull on the cord. Always disconnect the plug from the wall socket in order to disconnect the heated bowl holder from the power supply. To put the heated bowl holder into service first connect it to the power supply and then turn it on at the main switch (1). ⌧ To switch on the unit, first turn off the main switch (1) and then attach the plug at the wall socket. Then turn on the main switch. ⌧ To switch off the machine first turn off the main switch and then disconnect the plug from the wall socket.

1

Fig. 5: Switch on bowl holder

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

13

3 3.3.2

Use Heating

Set the temperature

DANGER! The temperature indication may be skewed if the original-equipment bowl is not used. The temperature of the solution may then be considerably above or below the value shown and thus can give rise to a life-threatening situation for the patient. Use only the original-equipment bowl.

DANGER! The temperature will rise above the set-point temperature if there is less than 1 litre of fluid in the bowl. Always fill the bowl with at least 1 litre of liquid so as to avoid heating beyond the set-point temperature.

WARNING! The temperature distribution may not be uniform where a larger volume of liquid is present. That is why it is important to stir the liquid before it is used.

WARNING! Poor heat transfer and temperature regulation will result if the heating plate or the temperature sensor is soiled or if there are objects or drapes between the heating plate and the bottom of the bowl. Thus it is necessary to ensure that the heating plate and temperature sensor are clean and that there are no objects between the heating plate and the bottom of the bowl. The control panel serves not only to make the desired settings but also for optical monitoring of the unit by the user. A default set-point temperature of 38 °C is always set when the unit is switched on. The set-point temperature can be changed using the appropriate button.

instructions Heated bowl holder 4904.9500/9600 14 Operating GA 4904.95 EN 03

The set-point temperature which has been set Is shown at the LED array: • Yellow: 35 °C. • Green: 38 °C and 40 °C. • Red: 45 °C to 60 °C.

Use Heating

3

1 2 3

4 6 5

Fig. 6: Heating control panel 1 LED array (yellow, green, red) The illuminated LED shows the set-point temperature selected. 2 EXCESS TEMPERATURE LED (red) in the red area lights if the current temperature rises above the set-point value. 3 The OK LED (green) in the green area lights when the current temperature corresponds to the set-point temperature.

4 INSUFFICIENT TEMPERATURE LED (yellow) in the blue area lights if the current temperature lies below the set-point value. 5 Pressing the set-point value button will change the set-point temperature. 6 The main switch, lights to show that the unit is switched on.

If the set-point temperature set set to values above 40 °C, then an acoustic signal will sound each time a button is pressed. ⌧ Press the set-point value button to change

the set-point temperature. The set-point temperature will jump to the next higher value each time the button is pressed; once a temperature of 60 °C has been reached the setpoint temperature will jump back to 35 °C. The set-point temperature selected can be read from the LED array.

Operating instructions Heated bowl holder 4904.9500/9600 GA 4904.95 EN 03

15

3

Use Heating

The bowl holder will heat the liquid in the bowl up to the set-point temperature. The LEDs in the thermometer graphic shows whether the current temperature lies below, above, or right

on the set-point temperature. You may remove the bowl once the set-point temperature has been reached and the green LED in the thermometer graphic lights.

DANGER! Where there are small quantities (1 to 2 l) of liquid in the bowl, the current temperature may overshoot the set-point temperature. The current temperature is then above the set-point temperature; the red LED in the thermometer graphic lights. In this case wait until the temperature drops and the green LED in the thermometer graphic lights. ⌧ Check to see whether the green LED in the

thermometer graphic is lit; only then may the bowl be removed.

NOTE The heating will also switch off automatically if there is no bowl on the heating plate. Then all the LEDs in the thermometer graphic will blink simultaneously.

WARNING! The heating plate remains hot after the bowl has been removed. This can cause burns. Do not touch the hot heating plate inadvertently.

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