IES 300 Instruction Manual V1.xx Feb 2000

IES 300 Instruction Manual

Peter Mock M.A. Technical Editor Tel. (+ 49) 70 71 75 52 37 E-Mail [email protected] It would be nice if this instruction manual contributed to easing your work and helped you utilize all the functions of your unit safely.

• It has been created by me in cooperation with developmental engineers and quality management with great care.

• Use of publishing software and digital photography have allowed the documentation team flexibility in design. Our objective: an attractive combination of text and photos.

• The translation of texts into your language is subject to strict quality control. • The instruction manual is printed out digitally only when shipping out your unit. All information is up to date. The ERBE documentation team would like to improve its products for you: I welcome your suggestions, criticism, questions, as well as any positive feedback.

ISO 9001 EN 46001

Instruction Manual Art. no. 80134-061 IES 300 Art. no. 10321-001, 10321-002 (Japan) All rights to this instruction manual, particularly the right to reproduction, distribution and translation, are reserved. No part of this instruction manual may be reproduced in any form (including photocopying, microfilm or other means), or processed, reproduced or distributed by means of electronic systems without prior written permission from ERBE Elektromedizin GmbH. The information contained in this instruction manual may be revised or extended without prior notice and represents no obligation on the part of ERBE Elektromedizin GmbH.

Printed by: ERBE Elektromedizin Printed in Germany Copyright © ERBE Elektromedizin GmbH, Tübingen 2000

Table of Contents

Chapter

Title ... Page

1

Intended use, safety instructions ... 7

2

Description of the controls ...11

3

Installation ... 13

4

Working with the IES 300 ... 19

5

Changing the basic settings on the programming level ... 23

6

Troubleshooting, cleaning and disinfection ... 27

7

Care, maintenance, disposal, customer service, guarantee ... 29

8

Technical data ... 31 Instructions for combining the IES 300 with electrosurgical equipment and accessories from other manufacturers ... 33 Addresses

Intended use, safety instructions • 1

CHAPTER 1

Intended use, safety instructions

Intended use With the vaporization of tissue, smoke and gases result during thermal surgical interventions. The IES 300 is a smoke extraction system. The unit is intended for use with smoke and gas generating medical equipment such as the laser surgical unit, electrosurgical unit and cautery. The IES 300 suctions in air contaminated with smoke. The air is cleaned by means of a high-performance filter and returned to the surrounding air. WARNING

Never use the IES 300 for anything other than medical purposes. Use of the IES 300 is forbidden for the following applications: • for drainage in the low-vacuum range (e.g. thorax drainage), • for suctioning off flammable or explosive liquids or gases.

Explanation of the safety instructions Make certain to read all safety instructions marked with an exclamation point before using the unit. WARNING

The WARNING safety instruction indicates a danger which can result in personal injury.

CAUTION

The CAUTION safety instruction indicates a danger which can result in property damage.

ATTENTION

The ATTENTION safety instruction indicates a danger which can cause functional failure of the unit.

Art. no. 80134-061 11 / 99

ERBE equipment is safe and controllable Safety of the procedure

With normal use and attention to the safety instructions, risks originating from this unit are controllable for users, patients, and the surroundings.

Your contribution to safety

Working with an electrical unit is always associated in principle with certain risks for the medical personnel and the patient. Risks cannot be completely excluded by constructive measures alone.

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1 • Intended use, safety instructions

Safety is dependent to a high degree on factors which are under your control. The safety instructions in this chapter are concerned with these factors. Safety of the unit

The unit conforms to all relevant, generally recognized rules of technology as well as the valid occupational safety and accident prevention regulations. This especially refers to electrical safety. An important component of the safety concept is the instruction manual. If you combine this unit with other ERBE products intended for this purpose, you will have a well-designed, harmonized system.

WARNING

Only use accessories approved by ERBE Elektromedizin. If not, ERBE Elektromedizin assumes no responsibility.

Instruction manual, training of medical personnel Who should read this instruction manual?

Everyone who prepares, adjusts, works with, dismantles, cleans or disinfects the unit and instrument set should read the unit instruction manual and the instructions for use for the instruments. Please pay particular attention to the safety instructions in every chapter.

Training

WARNING! The unit must only be used by persons who, under consideration of this instruction manual, have been trained in the proper handling. Training may only be conducted by persons whose knowledge and practical experience qualify them to do so. ERBE Elektromedizin GmbH assumes no liability for damage due to improper application.

Questions, criticism, suggestions?

If anything is unclear or if you have questions, please contact an ERBE employee or your local ERBE business office, the ERBE customer hotline, or the author of this instruction manual (publication details). We would be pleased to assist you and welcome your criticism and suggestions.

Protection against the risk of electrical shock WARNING! Inspect the unit and the accessories (e.g. instruments, pedals, cables, tubes) for damage before use. Never use a damaged unit or damaged accessories. Replace defective accessories. If the unit is damaged, please contact the Customer Service. For your safety and for that of your patient, never attempt to repair defective equipment or accessories. Any modification to the unit or accessories will exempt ERBE Elektromedizin from all liability.

Compare the supply voltage / supply frequency before connecting

WARNING! Compare whether the supply voltage and supply frequency of the unit agree with the values for the power supply. The supply voltage and supply frequency are indicated on the back of the unit and in the Technical Data. If in doubt, please contact the hospital technician or the power utility.

Art. no. 80134-061 11 / 99

Inspection of the unit and accessories

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Intended use, safety instructions • 1

Power cord, power outlet

WARNING! Only connect the power connection of the unit to a properly installed grounded socket using the power cord supplied by ERBE or one of at least equal quality. If you are using an equipment cart, this applies to the power cord on the equipment cart. The power cord must be labeled with the national test symbol. WARNING! For reasons of safety, never use a multiple power outlet or an extension cord.

No wet hands!

WARNING! Never touch the plug or lines with wet hands.

Power fuse

WARNING! The unit is protected with power fuses. If one of these fuses burns out, the unit can only then be used again on a patient if it has been inspected previously by a qualified technician. Only replacement fuses with the values indicated on the unit's rating plate may be used.

Potential equalization

WARNING! Connect the potential equalization pin on the unit to the potential equalization in the operating room.

Disconnecting the unit from the power supply

WARNING! If you wish to disconnect the unit from the power supply, pull the plug from the wall outlet. Only then disconnect the connecting line from the unit.

Art. no. 80134-061 11 / 99

Ambient, transport, and storage conditions No operation in potentially explosive zones

WARNING! The unit must only be operated in rooms intended for medical use. The unit is not intended for operation within potentially explosive areas (M and G). Potentially explosive areas may be created by the use of flammable anesthetics, skin cleaning agents and disinfectants.

Explosion-proof footswitch

WARNING! The footswitch must be suitable for operation within potentially explosive areas. Footswitches used in the operating room must have a watertight switch element (IPX 8).

Base

WARNING! Place the unit on a stable, level base. This must be able to bear a weight of at least 14 kg.

Operating conditions

ATTENTION: The unit should be operated at an ambient temperature between +10 °C and +40 °C. The relative humidity should be between 5 % and 95 %, noncondensing. If levels fall outside this tolerance range, the unit may malfunction.

Transport and storage conditions

ATTENTION: The unit can be transported and stored at a temperature between –40 °C and +70 °C. Extreme temperatures should be avoided, particularly in storage.

Acclimatization

ATTENTION: If the unit was stored or transported at temperatures below +10 °C, and especially below 0 °C, the unit requires approx. 4 hours to become acclimatized to ambient temperature.

Air circulation

ATTENTION: The unit must be set up in such a way that free air circulation around the housing in ensured. Setting up the unit in narrow corners or shelves is not permissible.

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1 • Intended use, safety instructions

Protection from moisture

CAUTION! The housing is not completely tight. Therefore do not set up the unit in the immediate vicinity of tubes or tanks that contain liquids. Do not suck up any liquid. If liquid has penetrated into the unit, it can only be operated after inspection by the Customer Service.

Dangers during application of the IES 300 WARNING! The IES 300 must only be operated by medical personnel and under supervision.

No contact with the suction site

WARNING! Never bring the suction hose into contact with the suction site. It could suck tight to the tissue.

Explosive gases

WARNING! Do not place the suction opening of the hose on the floor. Do not suction explosive endogenous gases (e.g. methane) from the intestinal tract.

System leakages

ATTENTION: If there are system leakages, the suction power display may fail.

Electromagnetic interferences

WARNING! If there are strong electromagnetic and line-associated interferences, sensitivity of the auto-activation must be reduced.

Note (only valid in the USA)

Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked "Hospital only" or "Hospital grade".

Caution

Electric shock hazard. Do not remove topcover. Refer servicing to qualified personnel.

Warning

For continued protection against fire hazard, replace only with a fuse same type and rating.

Danger

Explosion hazard if used in the presence of flammable anesthetics.

Caution

This equipment is for use only by qualified medical personnel trained in its use.

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Supervised operation

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Description of the controls • 2

CHAPTER 2

Description of the controls Fig. 1 Front panel

ERBE

IES 300

6

%

8

s 11

7

9

5

10

13 12

15 14

I !

O

2

3

4

1 (1) ON / OFF (2) The unit is defibrillator-protected (3) Suction start (4) Suction stop (5) Select: Operation suction, basic suction and run-on time are adjustable. Select the required function.

Art. no. 80134-061 11 / 99

(6) Operation suction: Suction power during activation of the electrosurgical unit or after manual start of the IES 300. Manual start using the suction start button or footswitch. (7) Run-on time: The operation suction continues running for a specific amount of time after deactivation of the electrosurgical unit or after releasing the suction start button or footswitch.

(8) Basic suction: During work breaks, the unit continues suctioning at reduced power. Suction power after completing the run-on time. (9) Higher value (10) lower value: Operation suction and basic suction can be set in the display (11) at a percent of maximum power of the unit. The run-on time is set in seconds. (12) Display of suction power (13) Display: System plugged (14) Display of filter capacity (15) Display: Filter expended

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2 • Description of the controls

Fig. 2 IES 300 with main filter

1

(1) Main filter lock

Fig. 3. Back of the IES 300 with electrosurgical unit

6

1 2 3

4

5

(1) Fuse drawer (2) Power outlet (3) Power outlet only for an electrosurgical unit (4) Potential equalization pin (5) Footswitch socket Art. no. 80134-061 11 / 99

(6) Power connection for the electrosurgical unit

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Installation • 3

CHAPTER 3

Installation

Initial operation Before delivery, the functions and the safety of the unit are tested. To ensure that the unit also functions safely after transport and installation at the operator's location, it must only then be put into operation if: 1. it has been subjected to a performance test at the operating site, and 2. the party responsible for operating the unit has been trained by the manufacturer or supplier in handling the unit by means of the instruction manuals.

Ambient conditions WARNING! The unit must only be operated in rooms intended for medical use. The unit is not intended for operation within potentially explosive areas (M and G). Potentially explosive areas may be created by the use of flammable anesthetics, skin cleaning agents and disinfectants.

Explosion-proof footswitch

The footswitch must be suitable for operation within potentially explosive areas. Footswitches used in the operating room must have a watertight switch element (IPX 8).

Base

Place the unit on a stable, level base. This must be able to bear a weight of at least 14 kg.

Operating conditions

The unit should be operated at an ambient temperature between +10°C and +40°C. The relative humidity should be between 5% and 95%, noncondensing. If levels fall outside this tolerance range, the unit may malfunction.

Acclimatization

If the unit was stored or transported at temperatures below +10°C, and especially below 0°C, the unit requires approx. 4 hours to become acclimatized to ambient temperature.

Air circulation

The unit must be set up in such a way that free air circulation around the housing in ensured. Setting up the unit in narrow corners or shelves is not permissible.

Protection from moisture

The housing is not completely tight. Therefore do not set up the unit in the immediate vicinity of tubes or tanks that contain liquids. Do not suck up any liquid. If liquid has penetrated into the unit, it can only be operated after inspection by the Customer Service.

Art. no. 80134-061 11 / 99

No operation in potentially explosive zones

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3 • Installation

Electrical installation Inspection of the unit and accessories

Inspect the unit and the accessories (e.g. instruments, pedals, cables, tubes) for damage before use. Never use a damaged unit or damaged accessories. Replace defective accessories. If the unit is damaged, please contact the Customer Service. For your safety and for that of your patient, never attempt to repair defective equipment or accessories. Any modification to the unit or accessories will exempt ERBE Elektromedizin from all liability.

Compare the supply voltage / supply frequency before connecting

Compare whether the supply voltage and supply frequency of the unit agree with the values for the power supply. The supply voltage and supply frequency are indicated on the back of the unit and in the Technical Data. If in doubt, please contact the hospital technician or the power utility.

Power cord, power outlet

Only connect the power connection of the unit Fig. 1 (2) to a properly installed grounded socket using the power cable supplied by ERBE or one of at least equal quality. If you are using an equipment cart, this applies to the power cable on the equipment cart. The power cord must be labeled with the national test symbol. For reasons of safety, never use a multiple power outlet or an extension cord.

No wet hands!

Never touch the plug or lines with wet hands.

Power fuse

The unit is protected with power fuses. These are found in the fuse drawer Fig. 1 (1). If one of these fuses burns out, the unit can only then be used again on a patient if it has been inspected previously be a qualified technician. Only replacement fuses with the values indicated on the unit's rating plate may be used.

Potential equalization

Connect the potential equalization pin on the unit Fig. 1 (4) to the potential equalization in the operating room.

Disconnecting the unit from the power supply

If you wish to disconnect the unit from the power supply, pull the plug from the wall outlet. Only then disconnect the connecting line from the unit.

Installation for activation of the IES 300 with a footswitch Connecting the footswitch

If you wish to activate the IES 300 using the footswitch, connect this to the footswitch socket Fig. 1 (5).

Installation for automatic activation of the IES 300 through an electrosurgical unit You have the option of always automatically switching on the suction when you activate the electrosurgical unit. If you wish to do this, install the IES 300 with the electrosurgical unit as follows: Join the power connection Fig. 1 (6) on the electrosurgical unit to the power outlet Fig. 1 (3) on the IES 300 using cable no. 51704-033. Art. no. 80134-061 11 / 99

Connecting the electrosurgical unit and IES 300

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Installation • 3

Fig. 1 Back of the IES 300 with electrosurgical unit

IES 300 and electrosurgery unit must be matched to one another in regard to the Automatic Activation. See Chapter 5 under Calibration of the Automatic Activation, manual and automatic. If you change the electrosurgery unit, you must recalibrate the Automatic Activation. 6

1 2

3

4

5

Installing the main filter The main filter is secured with 2 polystyrene blocks for transportation. Pull the main filter out of the filter shaft. Remove the polystyrene blocks. Insert the main filter Fig. 2 into the filter compartment on the unit until it clicks into place. Make certain the filter lock (1) is on the right side. Fig. 2 IES 300 with main filter

Art. no. 80134-061 11 / 99

1

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3 • Installation

Installing the suction accessories You have various options for suctioning smoke using the IES 300: Air hose with suction tube

On this suction device, the instrument and suction device are separate from one another. An assistant holds the suction tube and suctions off the smoke in the operating area. 1. Attach the air hose (1) to the main filter inlet. 2. Attach the in-line filter (2) to the air hose. 3. The in-line filter protects the air hose and the main filter from large particles. Be aware of the direction of flow. It is indicated on the in-line filter. Use only a clean, dry filter. 4. Attach the suction tube (3) to the in-line filter.

Fig. 3 Suction accessories: Air hose with suction tube

1

3 2

Electrode handle with smoke extraction

On this suction device, the suction channel is integrated into the electrode handle. 1. Attach the air hose for the electrode handle (1) to the main filter inlet. 2. Connect the HF plug for the electrode handle (2) to the electrosurgical unit.

Fig. 4. Suction accessories: Electrode handle with smoke extraction 2

Art. no. 80134-061 11 / 99

1

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Installation • 3

Electrode handle with smoke extraction attachment

On this suction device, the electrode handle is inserted into a smoke extraction attachment. 1. Insert the electrode handle into the smoke extraction attachment (1). The electrode handle snaps into place. 2. Attach the air hose for the smoke extraction attachment to the main filter inlet. 3. Connect the HF plug on the electrode handle (3) to the electrosurgical unit.

Fig. 5 Suction accessories: Electrode handle with smoke extraction attachment

3

2

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1

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3 • Installation

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Working with the IES 300 • 4

CHAPTER 4

Working with the IES 300

Electrical installation Connect the IES 300 to the power. Establish potential equalization (Chapter 3 Installation).

How would you like to activate the IES 300? Manual activation using the pedal

If you wish to activate the unit using a footswitch, connect this (Chapter 3 Installation).

Manual activation using the button

If you are not using the footswitch, you can also activate the unit using the suction start button.

Automatic activation of the IES 300 by way of an electrosurgical unit

You have the option of always connecting the suction automatically when you activate the electrosurgical unit. If you would like to do this, install the IES 300 with the electrosurgical unit. (Chapter 3 Installation).

Fig. 1

With which suction accessory would you like to work? Install: • the air hose with suction tube (Fig 1) or funnel. • an electrode handle with smoke extraction (Fig. 2). • or an electrode handle with smoke extraction attachment (Fig 3). Fig. 2

See Chapter 3 Installation. All parts which reach into the operating field and come into the proximity of or in contact with the patient must be sterile. This includes: • the suction hose, suction nozzle or suction set, • the electrode handle with air hose, • the electrode handle, smoke extraction attachment with air hose, in-line filter.

Fig. 3

Switching on the electrosurgical unit

Art. no. 80134-061 11 / 99

First switch on the electrosurgical unit. If you first switch on the IES 300, the extractor is started.

Switching on the IES 300 Switch on the power switch. The IES 300 conducts a self-test. All displays are illuminated.

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4 • Working with the IES 300

Setting the IES 300 Operation suction, basic suction and run-on time are adjustable. Select the required function.

Select

Using the buttons higher value / lower value, you can change the value of the selected function. Higher value

Lower value

The value can be seen in the display. Here it is either a display in percent or a display in seconds. The percent or the second symbol is illuminated. Information in percent relates to the maximum output of the unit.

Setting the operation suction

The operation suction is the suction power during activation of the electrosurgical unit or after manual start of the IES 300. Manual start or manual deactivation is understood to mean the use of a footswitch or the suction start button. Using the higher value / lower value buttons, select a value between 20% and 100%. If you require a particularly high suction power, you can set the operation suction higher than 100%. Using the higher value button, select a value above 100%. The word on will appear in the display. Unrestricted use of this maximum power [on] of the unit is only possible if there is free flow. If narrow tubes and connections are fitted, or if the filter is dirty, the unit will automatically reduce the power.

Setting the run-on time

After deactivation of the electrosurgical unit or after manual deactivation of the IES 300, the operation suction continues to run for a certain amount of time. This time interval is the run-on time. Using the higher value / lower value buttons, select a value between 0 and 100 seconds.

Permanent operation suction

It is also possible to allow the Operation suction to continue running for an unspecified period of time after deactivation of the electrosurgical unit or after manual deactivation of the IES 300. Using the higher value button, select a value greater than 100 seconds. The word on: Permanent operation suction on, appears in the display. The permanent operation suction can be switched on or off using the footswitch.

Setting the basic suction

During work breaks, the unit continues suction at reduced power. The basic suction is the suction power after the run-on time has finished.

The basic suction is switched off after a certain period of time. This time interval, the basic suction time, can be set on the programming level. The basic suction time is between 0 and 98 seconds. Basic suction is also possible for an unlimited time. The unit is delivered with this setting.

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Art. no. 80134-061 11 / 99

Using the higher value / lower value buttons, select a value between 0 % and 30 %.

Working with the IES 300 • 4

Fig. 4 Example of the time characteristic operation suction, run-on time and basic suction

Run-on time for operation suction: 5 seconds

Operation suction: 100%, 5 seconds 100

P (%) 80

60

Basic suction: 30%, for unspecified time

40

20

0

2

4

6

8

10

t (sec)

20

Suction WARNING

Position the suction hose in such a way that it does not accidentally suck up swabs etc.

Manual activation using pedal or button

Press the suction start button or the footswitch. The unit continues suctioning until you press the button or the footswitch. Suction continues for the duration of the set run-on time and finally the basic suction for the duration of the set basic suction time. Using the suction stop button, you can stop all suctioning immediately.

Automatic activation of the IES 300 by way of an electrosurgical unit

Activate the electrosurgical unit. The unit continues suctioning as long as you cut or coagulate. Suction then follows for the duration of the set run-on time and finally the basic suction for the duration of the set basic suction time. Using the suction stop button, you can immediately stop all suctioning.

Monitoring the suction with the display elements This display indicates the air resistance occurring in the airway through the hose and filter system. If all green bars are illuminated, the suction power is high. The system is clear. The fewer bars which are illuminated, the lower the suction power. If the system is completely plugged, all green bar displays disappear and the system plugged display is illuminated in red. Fig. 4

Suction capacity

Art. no. 80134-061 11 / 99

System plugged

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4 • Working with the IES 300

The filter capacity display permits an overview of the filter status. The more green bar displays which are illuminated, the greater the capacity still available. Fig. 5

Filter capacity

Filter expended

Filter display

No Filter

When switching on the unit

Display filter expended

Green bar displays

illuminated

none

Display Warning Activation tone possible? none

no

Filter in the reserve range (remaining time: 2 hrs suction at 100% efficiency) When switching on the unit

illuminated

none

none

yes

When activating

illuminated

none

none

yes

When switching on the unit

blinks

none

3 times

yes

When activating

blinks

none

none

yes

Filter expended

Art. no. 80134-061 11 / 99

FIL for 6 sec.

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