IES 2 User Manual V1.3.x Sept 2005

IES 2 User manual

Peter Mock Technical Editor Tel. (+ 49) 70 71 75 52 37 E-mail [email protected]. I shall be very pleased if this User Manual can make your work easier and help you to use all the functions of your unit safely. It has been produced with great care by me in collaboration with development engineers and quality personnel. The use of publishing software and digital photography provided the documentation team with layout flexibility. Our object was to achieve a clear combination of text and photographs. The translation of the text into your language is subjected to a strict quality control. The User Manual is digitally printed only on delivery of your machine. All information is up to date. The ERBE documentation team would like to improve its products for your benefit, and I would therefore be very pleased to receive suggestions, criticism and questions as well as positive comments.

EN ISO 9001 EN ISO 13485 User Manual Art. No. 80134-101 Unit Art. No. 10322-000 All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this User Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or disseminated by the use of electronic systems without the written consent of ERBE Elektromedizin GmbH. The information contained in this User Manual can be changed or expanded without prior notice and without obligation on the part of ERBE Elektromedizin GmbH. Printed by ERBE Elektromedizin Printed in Germany Copyright © ERBE Elektromedizin GmbH, Tübingen 2005

Table of Contents

Table of Contents

Chapter 1

Title

Page

Safety instructions ... 7 Intended use ... 7 Safety notations... 7 Safety of equipment and accessories ... 7 Importance of the User Manual and training of medical personnel... 7 Protection from the risk of electric shock ... 8 Ambient conditions ... 8 Maintenance ... 9 Risks when using the IES 2 ... 9

2

Description of the Controls ... 11 Controls on the front panel ... 11 Controls on the back ... 13

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3

Working with the IES 2 as a stand-alone unit... 15 Switching on IES 2 ... 15 Setting IES 2 ... 15 Suction ... 15

4

Working with the IES 2 in combination with a VIO from the D series ... 17 Switch on the VIO System... 17 Setting IES 2 ... 17 Checking the smoke evacuation in the Cut / Coag settings window. ... 19 Suction ... 19

5

Working with the IES 2 in combination with a VIO from the S series... 21 Extended activation relative to the IES 2 stand-alone unit ... 21 Functions/setting options of the IES 2 ... 21 Important aspects when setting the IES 2 ... 22 Switching on the VIO system and IES 2 ... 23 Activating/deactivating the suction function ... 23 Setting other parameters on the IES 2... 25 Checking the settings ... 27 Suction ... 27

6

Special functions... 29 Calling up the basic setting ... 29 Calling up the setting functions ... 29

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Table of Contents

7

Installation... 31 Ambient conditions ...31 Electrical installation ...31 Installation of the IES 2 as a stand-alone unit ...32 Installing the unit on an ERBE equipment cart ...34

8

Cleaning and Disinfection ... 37 Wipe disinfection...37 Instructions for cleaning and disinfection ...37 Safety Instructions ...37

9

Technical data... 39

10

Information on electromagnetic compatibility (EMC) ... 41

11

Maintenance, Customer Service, Warranty, Disposal... 45

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Maintenance ...45 Customer service ...45 Warranty ...45 Disposal ...45

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1 • Safety instructions

CHAPTER 1

Safety instructions

Intended use The vaporization of tissue during thermal surgical interventions produces smoke and gases. The IES 2 is a smoke evacuator system. The unit is intended for use with smoke and gas-generating medical devices such as laser surgery and electrosurgical units and cauteries. You can use the IES 2 as a stand-alone unit or in combination with the VIO surgical unit. The IES 2 extracts the smoke-laden air. The air is cleaned by a high-performance filter and returned to the ambient air. WARNING!

Use of the IES 2 for drainage in the low vacuum range (e.g. thorax drainage) and for the extraction of combustible, explosive liquids, gases or radiating or radioactive substances is forbidden.

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Safety notations WARNING!

The WARNING! safety indication refers to a risk of personal injury.

CAUTION!

The CAUTION! safety indication refers to a risk of damage to property.

ATTENTION:

The ATTENTION: safety indication refers to a risk which can cause equipment to become unserviceable.

Safety of equipment and accessories Compliance with safety information

Appropriate application of and compliance with the safety information makes a considerable contribution to the safety of the user, patients, and environment.

Safety of equipment and instruments

ERBE devices complys with all relevant and generally accepted engineering practices as well as with the applicable occupational protection and accident prevention regulations.

Combination with other equipment

You can combine this device with other ERBE equipment and instruments. You will then have a well-conceived, coordinated system.

Contribution of medical personnel to safety

Working with medical equipment is basically associated with certain risks to medical personnel and patients. Risks cannot be entirely eliminated by design measures alone. Safety does not depend solely on the equipment but depends to a large extent on factors influenced by you. These factors are dealt with in the safety information in this chapter.

Importance of the User Manual and training of medical personnel Who should read this User Manual?

The User Manual forms an important part of the safety concept of the unit. Therefore everyone who is concerned with

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1 • Safety instructions

•

preparing,

•

adjusting,

•

operating,

•

disassembling, as well as

•

cleaning and disinfecting

the unit and instruments as applicable should read the User Manual and the instructions for using the instruments. Please pay particular attention to the safety instructions in each chapter. Training

WARNING! The equipment must be used only by medical professionals who have been appropriately trained (In-Serviced) and authorized by ERBE. Training must be carried out only by personnel who are suitable on the basis of their knowledge and practical experience. ERBE is not responsible for damage caused by user error. In the event of uncertainties or if you have any questions, please contact ERBE. We will be glad to give you further assistance and will be pleased to receive your suggestions concerning this User Manual.

Leakage current

The equipment conforms to the requirements of Type CF (Cardiac Float) and is protected against the effects of a defibrillator discharge.

Inspecting the equipment, equipment cart, accessories

WARNING! Inspect the equipment or equipment cart and the accessories (e.g. foot control, cable) for damage after every period of use. You must not use damaged equipment, a damaged equipment cart or damaged accessories. Exchange defective accessories. If the equipment or equipment cart is damaged, please contact our customer service. For your safety and that of patients, never attempt to effect repairs yourself. Any modification will invalidate liability on the part of ERBE Elektromedizin GmbH.

Power cord, power outlet

WARNING! The supply voltage must match the voltage specified on the rating plate. Connect the unit / the equipment cart to a properly installed grounded outlet. Only use the ERBE power cord or an equivalent power cord for this purpose. The power cord must bear the national test symbol.

Power fuses

WARNING! The unit is protected with power fuses. They can be found in the fuse drawer next to the power connection of the unit. If one of these power fuses has blown, the unit may not be used on the patient again until it has been checked by a competent technician. Only spare fuses with the values indicated on the unit rating plate may be used.

Potential equalisation

If necessary, connect the potential equalisation pin of the unit or of the equipment cart to the potential equalisation system of the operating room using a potential equalisation conductor.

Ambient conditions

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Do not operate in potentially explosive atmospheres

WARNING! The device may only be operated in rooms used for medical purposes. Position the device in such a way that it is located outside of potentially explosive atmospheres. Potentially explosive atmospheres can form due to the use of combustible anesthetics, skin cleansers and disinfectants.

Operating conditions

ATTENTION: The device must be operated at a certain temperature and humidity. You will find the specified temperature and humidity in the Technical Data. If levels exceed or fall below the tolerances specified there, the device may fail. If other con-

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Protection from the risk of electric shock

1 • Safety instructions

ditions have to be observed for operation of this device, you will also find them in the Technical Data. Portable and mobile communication equipment HF

ATTENTION: Portable and mobile communication equipment HF can influence the device.

Transport and storage

ATTENTION: The device must be stored and transported at a certain temperature and humidity. You will find the specified temperature and humidity in the Technical Data. If levels exceed or fall below the tolerances specified there, the device may fail. If other conditions have to be observed for operation of this device, you will also find them in the Technical Data.

Acclimatization

ATTENTION: If the device was stored or transported below a certain temperature, it will take a certain time to acclimatize to room temperature. You will find the temperature and acclimatization time in the Technical Data.

Ventilation

ATTENTION: The device must be installed in such a way that there is an unobstructed circulation of air around the housing. Installation in confined wall recesses is not permitted.

Penetration of liquids

ATTENTION: The housing is not absolutely watertight. Therefore do not place the device in the immediate vicinity of tubes or tanks containing liquids.

Maintenance WARNING! The unit must undergo a safety check at least once a year.

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Risks when using the IES 2 Supervised operation

WARNING! The IES 2 may only be operated by medical staff and under supervision.

Footswitch class AP, IPX 8

NOTE: For safety reasons you can only use the ERBE footswitch no. 20322-100 with the IES 2. This footswitch is suitable for use in the potentially explosive area of the operating room (class AP). The footswitch is watertight (IPX8).

Surface

WARNING! Place the unit on a stable, level surface. It must be able to support a weight of at least 14 kg.

No contact with the suction site

WARNING! Never bring the suction tube into contact with the suction site. It could become fixed to the tissue.

Swabs

WARNING! Position the suction device, or the instrument with suction device, so that it cannot accidentally suck up swabs or the like.

Liquids

ATTENTION: Do not suck up any liquids. If there is a risk that you could suck up liquids during the operation, attach an in-line filter on the main filter. Replace the in-line filter immediately if you have sucked up any liquid.

Explosive gases

WARNING! Do not place the tube's suction opening on the floor. Do not extract any explosive endogenous gases (e. g. methane) from the intestinal tract.

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1 • Safety instructions

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2 • Description of the Controls

CHAPTER 2

Description of the Controls

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Controls on the front panel

Fig. 2-1

(1) Power switch Symbol

Unit On / Off (1a) Read the User Manual before switching on and using the unit.

(2) Heart symbol

The unit is defibrillator-protected.

(3) Main filter lock

Releases the main filter from the unit.

(4) Main filter input

Connection of the suction accessories.

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2 • Description of the Controls

(5) Operation suction

Suction capacity during activation of the electrosurgical unit or after manually starting the IES 2. Manual start with theStart suction buttonor the footswitch.

(6) Basic suction

During work breaks, the unit operates at reduced capacity. Suction capacity after the Run-on time has ended.

(7) Run-on time

The operation suction runs on for a set length of time after the electrosurgical unit is deactivated or after the Start suction button or the footswitch is released.

(8) Display

Shows the values of Operation suction, Basic suction, Run-on time and various special functions.

(9) Start suction

The unit operates for as long as you press the button.

(10) Seconds symbol

Illuminates when the Run-on time is being set.

(11) Percent symbol

Illuminates when Operation suction and Basic suction are being set. You set these on the display as a percentage of the unit's maximum capacity.

(12) Higher / Lower

Buttons for adjusting the values shown on the display.

(13) Filter exhausted indicator

Illuminates when the filter is in the reserve range. Flashes when the filter is exhausted.

(14) System blocked indicator

Illuminates when the system is blocked, e. g. if you have sucked up an object.

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Fig. 2-2

2 • Description of the Controls

Controls on the back

Fig. 2-3

Connect an equipotential bonding conductor and attach this to the equipotential bonding system of the operating room. If you are using the ERBE VIO-CART, connect the equipotential bonding conductor to the equipotential bonding pin of the VIO-CART.

(2) Power connection

Connect the unit to a properly installed grounded outlet. Only use the ERBE power cord or an equivalent power cord for this purpose. The power cord must bear the national test symbol. If the unit is installed on the ERBE VIO-CART, make the power connection with the power cord of the VIO-CART.

(3) Power fuses

The unit is protected with power fuses. If one of these power fuses has blown, the unit may not be used on the patient again until it has been checked by a competent technician. The values of the power fuses are specified on the unit's rating plate . Only spare fuses with these values may be used.

(4) Footswitch socket

You can connect a single-pedal footswitch to this socket if you are operating the IES 2 as a stand-alone unit.

(5) ECB socket

You can use the VIO electrosurgical unit as a control unit, in which case the functions of the IES 2 are shown on the display. The ECB (ERBE Communication Bus) ensures communication between the units. Connect an ECB cable to this socket and connect the cable to one of the other units of the VIO system. You will find details in the chapter "Installation".

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Equipotential bonding

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2 • Description of the Controls

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3 • Working with the IES 2 as a stand-alone unit

CHAPTER 3

Working with the IES 2 as a stand-alone unit

Switching on IES 2 Switch on the power switch. The IES 2 performs a self-test. All the displays illuminate.

Setting IES 2 Operation suction, Basic suction and Run-on time are adjustable. Select the desired function. Using the Higher / Lower buttons you can change the value of the selected function. The figure that you see on the display is either a percentage or seconds. The percentage symbol or seconds symbol illuminates. The percentage figure refers to the unit's maximum output. Operation suction is the suction capacity during activation of the electrosurgical unit or after manually starting the IES 2. The terms manual start and manual deactivation mean the use of a footswitch or the Start suction button. Select a value between 20% and 100% using the Higher / Lower buttons. 100% corresponds to a suction capacity of approx. 650 l/min.

Setting the run-on time

The operation suction runs on for a specified length of time after the electrosurgical unit is deactivated or after manual deactivation of the IES 2. This period of time is the Run-on time . Select a value between 0 and 10 seconds, using the Higher / Lower buttons.

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Setting Operation suction

You can also let the operation suction continue running for an indefinite period after deactivation of the electrosurgical unit or after manual deactivation of the IES 2. Select a period longer than 10 seconds, using the Higher / Lower buttons. The word "On",: meaning Permananent Operation suction appears on the display. The Permananent Operation suction can be switched on and off with the footswitch or the Start suction button. Setting the Basic suction

During work breaks, the unit operates at reduced capacity. The Basic suction is the suction capacity after the Run-on time has ended. Select a value between 0% und 30% using the Higher / Lower buttons. The Basic suctionis switched off after a specified time. You can set this period of time, known as the Basic suction time, at the program level. The Basic suction time is between 1 and 99 seconds. Basic suction without any time limit is also possible: "On" setting at the program level.

Suction WARNING!

Position the suction device, or the instrument with suction device, so that it cannot accidentally suck up swabs or the like. Press the Start suction button or the footswitch. The unit operates for as long as the button or footswitch is pressed. Suction then continues for the duration of the set Run-on time,after which Basic suction takes place for the duration of the set Basic suction time.

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3 • Working with the IES 2 as a stand-alone unit

Never bring the suction tube into contact with the suction site. It could become fixed to the tissue.

ATTENTION:

Do not suck up any liquids. If there is a risk that you could suck up liquids during the operation, attach an in-line filter on the main filter. Replace the in-line filter immediately if you have sucked up any liquid.

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WARNING!

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4 • Working with the IES 2 in combination with a VIO from the D series

CHAPTER 4

Working with the IES 2 in combination with a VIO from the D series

Switch on the VIO System Performance test

Use the power switch to switch the unit on. The unit then carries out a performance test and checks all the sockets. Connected units and footswitches are detected. All indicator lights and focus buttons illuminate. The version number of the software appears on the display.

Getting an overview: Assignment of the active program

Once the performance test has been completed, you will see the Directory window.. On the right side of the window you can see the assignment of the active program. In this example it is the basic program. The sockets of your individual unit are displayed schematically. This provides you with answers to the question: Which CUT / COAG mode, which effect, and what capacity are active for which socket? Press any button to confirm that you have checked the settings of the active program. Superimposed on the Directory window you will see a small window with the message: Check settings of active program. Please press any button to confirm.

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Only when you have complied with this prompt will you have access to the active program and the functions of the Directory window.

Setting IES 2 Scroll to the IES function

Press the Down button on the front panel of the electrosurgical unit and keep it pressed until you see the IES 2 settings for VIO 300 D window. You can also scroll to the IES 2 settings for APC window.

Calling up the window for setting the IES

Fig. 4-1

Press the Select button next to the VIO socket for which you wish to set the IES.

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4 • Working with the IES 2 in combination with a VIO from the D series

Fig. 4-2

You can now set the IES functions for the active program and all the sockets. At the top right of the display (1), you can see the socket to which the settings apply. In our example display, it is the monopolar socket. If you wish to set the IES functions for another socket, press the focus button next to the respective socket.

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The setting process

Fig. 4-3

You can set the Cut suction, Coag suction, the Basic suction, and the Run-on time, for each socket. The setting process is always the same and is only described once. Press the selection button next to the desired function, e.g. Cut suction Set a value using the Up / Down buttons on the front panel of the electrosurgical unit. If you only wish to set this one function, press the Enter button on the front panel of the electrosurgical unit. You thereby accept the value and return to the Directory window. Press the selection button next to another function, e.g. Coag suction, if you also wish to change this. By changing the IES settings you have also modified the basic program. You can save the program under a new name. To do this, read the passage: Saving the amended basic program You will find the passage in the User Manual of the VIO electrosurgical unit.

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Cut suction

Cut suction is the suction capacity during activation of the electrosurgical unit. Select a value between 20% and 100%. 100% corresponds to a suction capacity of approx. 650 l/min. You can also put Cut suction to Off. In this case, the IES is not activated during activation of the Cut mode.

Coag suction

Coag suction is the suction capacity during activation of the electrosurgical unit. Select a value between 20% and 100%. 100% corresponds to a suction capacity of ap-

4 • Working with the IES 2 in combination with a VIO from the D series

prox. 650 l/min. You can also put Coag extraction to Off. In this case, the IES is not activated during activation of the Coag mode. Run-on time

The Cut suction or Coag suction runs on for a specified length of time after the electrosurgical unit is deactivated. This period of time is the Run-on time. . Select a value between 0 and 10 seconds.

Basic suction

During work breaks, the suction unit operates at reduced capacity. The Basic suction is the suction capacity after the run-on time has ended. Select a value between 0% and 30%. The Basic suctionis switched off after a specified time. You can set this period of time, known as the Basic suction time, at the program level. The Basic suction time is between 1 and 99 seconds. Basic suction without any time limit is also possible. "On" setting at the program level.

Checking the smoke evacuation in the Cut / Coag settings window.

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Fig. 4-4

If the signal in the Cut / Coag settings window is green, smoke evacuation begins automatically when the respective mode is activated. In the example display, the smoke evacuation is switched off for Cut (1) and active for Coag (2).

Suction WARNING!

Position the suction device, or the instrument with suction device, so that it cannot accidentally suck up swabs or the like.

WARNING!

Never bring the suction tube into contact with the suction site. It could become fixed to the tissue. Activate the electrosurgical unit. The IES evacuates for as long as you activate the electrosurgical device. Suction then continues for the duration of the set Run-on time,after which Basic suction takes place for the duration of the set Basic suction time.

ATTENTION:

Do not suck up any liquids. If there is a risk that you could suck up liquids during the operation, attach an in-line filter on the main filter. Replace the in-line filter immediately if you have sucked up any liquid.

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4 • Working with the IES 2 in combination with a VIO from the D series

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5 • Working with the IES 2 in combination with a VIO from the S series

CHAPTER 5

Working with the IES 2 in combination with a VIO from the S series

Extended activation relative to the IES 2 stand-alone unit When the VIO HF surgical unit is activated, the IES 2 is switched on automatically for the duration of activation. Prerequisites: •

The IES 2 is connected to a VIO (from version 1.1.0) via the ECB interface (ERBE Communication Bus).

•

The suction function was activated via the VIO.

Functions/setting options of the IES 2 In combination with a VIO from the S series the IES 2 provides you with the following setting options: Activation/deactivation of the suction function

If the suction function has been activated, the IES 2 starts the suction process automatically when the HF current is activated via the VIO.

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You can activate the suction function for Cut HF current and Coag HF current for each HF receptacle separately. This applies to all the HF receptacles on the VIO and all the HF receptacles on add-on modules (e.g. APC 2). Example: If you have activated the Coag suction function for the first Monopolar receptacle on the VIO, suction starts automatically when you activate Coag HF current via the first Monopolar receptacle on the VIO. As required you can, in addition, also start suction manually on the IES 2 using the Start suction button or the footswitch. Cut suction

Cut suction is the suction capacity during activation of the Cut HF current of the VIO. You can select a value between 20% and 100%. 100% corresponds to a suction capacity of approx. 650 l/min.

Coag suction

Coag suction is the suction capacity during activation of the Coag HF current of the VIO. You can select a value between 20% and 100%. 100% corresponds to a suction capacity of approx. 650 l/min.

Run-on time

Cut suction and Coag suction run on for a specified length of time after the electrosurgical unit is deactivated. This period of time is the Run-on time. You can select a value between 0 and 10 seconds.

Basic suction

During work breaks, the unit operates at reduced capacity. Basic suction is the suction capacity after the Run-on time has ended. You can select a value between 0% and 30%. Basic suction is switched off after a specified time. You can set this period of time, known as the Basic suction time, at the program level. The Basic suction time is between 1 and 99 seconds. Basic suction without any time limit is also possible: On setting at program level.

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