Erbe Erbokombi E User manual
ERBOKOMBI E / OPHTHALMOTOM
Instruction Manual
06.99
ERBOKOMBI E / OPHTHALMOTOM
Instruction Manual
Peter Mock M.A.
Technical Editor
Tel. (+ 49) 70 71 75 52 37
E-Mail pmock@erbe-med.de
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. 80172-211
Erbokombi E Art. no. 10732-002
Ophthalmotom Art. no. 10738-002
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 1999
Table of Contents
Chapter Title
1 Intended use, safety instructions
2 Description of the application possibilities, description of the controls
3 Installation
4 Working with the Erbokombi E, Ophthalmotom
5 Cleaning, disinfection
6 Maintenance, care, disposal
7 Customer service and guarantee
8 Technical data
Addresses
CHAPTER 1
Intended use, safety instructions
Intended use
The Erbokombi E and the Ophthalmotom are equipment for ophthalmology.
This equipment has the following functions:
· High-frequency monopolar current for coagulation of vessels, penetration,
marking, and epilation.
· High-frequency bipolar current for coagulation of intraocular hemorrhages
and for “pre”-coagulation with scleral incision, wet-field coagulation.
Intended use, safety instructions • 1
WARNING
CAUTION
ATTENTION
· Cathode-electrolysis for the performance of subretinal drainage,
cauterization of the tear ducts.
· Electrocautery connection for coagulation of minor scleral hemorrhages.
· Cryosurgical module for the Erbokombi E. Cryotherapy of primary
glaucoma, cryoretinopexy, cataract extraction, trichiasis, foreign body
extraction.
· Cryo-preselection option on the Ophthalmotom.
· Cold light source for intraocular and transscleral illumination.
Explanation of the safety instructions
Make certain to read all safety instructions marked with an exclamation point
before using the unit.
The WARNING safety instruction indicates a danger which can result in
personal injury.
The CAUTION safety instruction indicates a danger which can result in
property damage.
The ATTENTION safety instruction indicates a danger which can cause
functional failure of the unit.
Safety of the procedure
Your contribution to safety
ERBE equipment is safe and controllable
With normal use and attention to the safety instructions, risks originating
from this unit are controllable for users, patients, and the surroundings.
W orking 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.
1
1 • Intended use, safety instructions
Safety of the unit
WARNING
Who should read this instruction
manual?
Training
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.
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.
Only use accessories approved by ERBE Elektromedizin. If not, ERBE
Elektromedizin assumes no responsibility .
Instruction manual, training of personnel
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.
W ARNING! The unit must only be used by persons who, under consideration
of this instruction manual, have been trained in the proper handling.
Questions, criticism,
suggestions?
Inspection of the unit and
accessories
Compare the supply voltage /
supply frequency before
connecting
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.
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 .
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.
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.
2
Intended use, safety instructions • 1
WARNING! For reasons of safety, never use a multiple power outlet or an
extension cord.
No wet hands!
Power fuse
Potential equalization
Disconnecting the unit from the
power supply
Risk of fire and explosion
WARNING! Never touch the plug or lines with wet hands.
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.
W ARNING! Connect the potential equalization pin on the unit to the potential
equalization in the operating room.
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.
Ambient, transport, and storage conditions
W ARNING! Electrosurgical equipment intentionally generates electric sparks
between the active electrode and tissue. Electric sparks may also result within
the unit. For this reason, electrosurgical equipment must never be used in
potentially explosive areas. Considered potentially explosive is the area up
to 20 cm above the floor and the area around and beneath the operating table,
if inflammable or explosive cleaning agents, disinfectants, anesthetics etc
are used. This also includes highly concentrated or even pure oxygen. Highfrequency surgical equipment is normally installed outside the zone.
Explosion-proof footswitch
Base
Operating conditions
Transport and storage
conditions
Acclimatization
Air circulation
W ARNING! The footswitch must be suitable for operation within potentially
explosive areas. Footswitches used in the operating room must have a
watertight switch element.
WARNING! Place the unit on a stable, level base. This must be able to bear
a weight of at least 14 kg.
A TTENTION: The unit should be operated at an ambient temperature between
+10°C and +30°C. The relative humidity should be between 30% and 70%,
noncondensing. If levels fall outside this tolerance range, the unit may
malfunction.
A TTENTION: The unit can be transported and stored at a temperature between
-40°C and +70°C. Extreme temperatures should be avoided, particularly in
storage.
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.
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.
Protection from moisture
CAUTION! The housing is not completely tight. Make certain that no liquid
penetrates into the unit. If liquid has penetrated into the unit, it can only be
operated after inspection by the Customer Service.
3
1 • Intended use, safety instructions
Safety instructions for electrosurgical equipment
Unintentional thermal tissue
damage
Unintentional thermal tissue
damage due to HF leakage
currents
Electrosurgery is associated in principle with various risks for the patient,
the personnel and the surroundings. In order to prevent these risks in practice,
the surgeon and his/her assistants must recognize these risks and observe the
appropriate rules for prevention of injuries. In the following, these risks and
rules for prevention of injuries are presented.
During electrosurgery, the patient unavoidably conducts high-frequency
electrical current to ground potential. If the patient makes contact with
electrically conductive objects during electrosurgery, a high-frequency
electrical current can result at the contact point between the patient and this
object, which in turn can cause thermal necroses. Not only objects made of
metal are electrically conductive, but also wet cloths.
WARNING! The patient must be insulated against electrically conductive
objects during electrosurgery. The black elastic table covers on operating
tables demonstrate a certain electrical conductivity to divert electrical charges.
Therefore they are never suitable for ensuring the required insulation of the
patient against metal parts of the operating table. For this reason, an electrically
insulating intermediate layer, for example dry cover cloths, must be laid
between the patient and the black operating table cover during application of
electrosurgery .
Unintentional activation of an HF
generator
Fig: Insulated positioning of the patient on the operating table.
If it is possible for this intermediate layer to become wet during the operation,
for example due to perspiration, irrigation liquid, urine etc., wetting of these
intermediate layers must be prevented by a watertight sheet of plastic. Urine
should be carried away via catheter.
Extremities lying against the trunk or skin-to-skin contact points should be
insulated from one another by laying dry cover cloths between them.
WARNING! Do not apply ECG electrodes closer than 15 cm next to the
operating field. Needle electrodes or injection cannulas should not be used as
ECG electrodes during high-frequency surgery.
WARNING! Unintentional activation of an HF generator can lead to burns
on the patient if the active electrode hereby touches the patient directly or
indirectly through electrically conductive objects or wet cloths.
Unintentional activation of an HF generator can, for example, be caused by:
Unintentionally pressing a footswitch pedal
Unintentionally pressing a fingerswitch
Defective fingerswitches, footswitches or cables
4
Intended use, safety instructions • 1
Penetration of electrically conductive liquids (blood, amniotic fluid, urine,
physiological saline solution, irrigation fluids etc.) into fingerswitches or
footswitches.
Errors within the electrosurgical unit
WARNING! To prevent burns on the patient due to unintentional activation
of a high-frequency generator, the following application rules should be
heeded:
Never lay active electrodes onto or beside a patient in such a way that they
can touch the patient directly or indirectly through electrically conductive
objects or wet cloths.
The lines to the active electrodes should be positioned in such a way that
they touch neither the patient nor other lines.
Always set the acoustic signal, which indicates the active status of the highfrequency generator, so that it can be easily heard.
In general, the bipolar coagulation technique should be applied in preference
to the monopolar coagulation technique.
Unintentional thermal tissue
damage
Inappropriate or nonapplication
of the neutral electrode
WARNING! Always make certain that the HF current does not flow through
thin tissue structures or vessels with a small diameter.
WARNING! With inappropriate or nonapplication of the neutral electrode,
there is a large risk of thermal tissue damage both at the application point of
the neutral electrode as well as to other areas on the patient’s body.
The neutral electrode must be applied with its entire surface as closely and
safely as possible to the operating field on the patient’s body, on the upper
arm during ophthalmology .
W ARNING! The effective contact surface, i.e. the electrical conductive value
between the neutral electrode and the patient must correspond to the HF
capacity used, meaning the intensity of the HF current. Here the effective
contact surface means the surface of the neutral electrode which has
electrically conductive contact to the skin of the patient during high-frequency
surgery .
a)
b)
Fig: The neutral electrode must be applied at an appropriate location on the
patient’s skin using the entire contact surface available (a). If the neutral
electrode has only partial contact to the patient’s skin (b), there is a risk that
burning will occur at this location.
5
1 • Intended use, safety instructions
Unsuitable or faulty accessories
Risk of fire and explosion
W ARNING! It must be ensured that only accessories in perfect condition are
used for electrosurgery . Only accessories that are compatible or tested by the
unit manufacturer must be used. This applies both to the active electrodes
including cables and plugs, as well as to the neutral electrodes including
cables and plugs.
W ARNING! When using an instrument with electric insulation, it is necessary
to be certain that these insulations are not overloaded and destroyed by overly
high electric voltages. The electric output voltages for the electrosurgical
unit are indicated for the various cutting and coagulation modes relative to
the possible settings in this instruction manual. The electric strength of the
instrument insulations can be found in the technical data for the instruments
or, in case of doubt, it can be requested from the manufacturer of the respective
instrument.
WARNING! All insulation for electrodes, electrode holders, cables, plugs
etc. must be in perfect condition.
W ARNING! Make certain during electrosur gical operations that anesthetics,
skin cleaning agents and disinfectants are nonflammable. If their use is
unavoidable, they must have completely evaporated and the vapor must be
removed from the area of spark formation before switching on the
electrosurgical unit. No anesthetic procedures must be applied which require
the use of highly concentrated or even pure oxygen.
Unintentional burns due to hot
electrodes
Electric shock
Cardiac pacemakers
WARNING! Coagulation electrodes become hot during coagulation
procedures indirectly due to the heated tissue and due to the electric arc.
Tissue can be unintentionally burnt immediately after coagulation procedures
if electrodes which are still hot touch the tissue.
An electric shock may occur if the electrosurgical unit delivers a too heavy
low-frequency current or if too heavy low-frequency current flows through
the patient into the electrosurgical unit from another voltage source.
A known risk of electrosur gery is the unintentional electric stimulation of the
patient’s nerves and muscles. This stimulation can result from low-frequency
electrical currents that are caused either by low-frequency current sources or
due to electrical arcs between an active electrode and the patient’ s tissue.
Electric alternating current with a frequency above 300 kHz is unable to
stimulate nerves and muscles.
W ARNING! When using electrosurgery on electrically stimulable structures,
contractions of the affected muscles must be taken into account.
WARNING! For patients with implanted cardiac pacemakers or pacemaker
electrodes, irreparable damage to the pacemaker and disturbance of the
pacemaker function, which can lead to ventricular fibrilation, must be
reckoned with.
6
Intended use, safety instructions • 1
Danger of explosion
Interference with other electronic
equipment
Carbonization of tissue
WARNING! Electrosurgical units always generate sparks on the active
electrode during operation. For this reason, it is necessary to make certain
during interventions that anesthetics, degreasers and disinfectants are neither
flammable nor explosive. They should at least have evaporated completely
before switching on the high-frequency surgical unit and be removed from
the area of spark formation. No anesthetic procedures should be applied in
which concentrated oxygen is used.
CAUTION! Electrosurgical units normally generate high-frequency electrical
voltages and currents which can interfere with other electronic equipment.
When installing or arranging sensitive electronic equipment in the operating
room, this problem should be taken into consideration. In principle, sensitive
electronic equipment should be set up as far as possible from the
electrosurgical unit and particularly from the cables providing the HF current.
In addition, the cables providing HF current, which act like broadcast antennas,
should not be unnecessarily long and should never be positioned parallel or
too close to cables from sensitive electronic equipment.
Safety instructions for cauterization
WARNING! The cautery loop must not become too hot: The tissue may
carbonize; the loop wears quickly and may burn through.
Burns caused by Cl
Burns caused by chlorine gas
Unsatisfactory effect or pain
Cardiac pacemaker
Storage of the refrigerant
or HCl
2
Select a maximum power setting at which the loop glows dark-red. T o check
this, look at the loop away from the bright operating room illumination.
Safety instructions for cathode-electrolysis
W ARNING! Neutral electrodes and hand cylinders must only be used together
with a well-moistened sponge. If the sponge is not used, the patient may be
burned by Cl2 or HCl.
W ARNING! The neutral electrode and/or the hand cylinder must be connected
to the red cable. The active electrode must be connected to the gray cable. If
the polarity is incorrect, chlorine gas may form.
WARNING! When epilating the cilia, start at a setting of 1.5 mA and work
your way up in 0.1 mA steps.
W ARNING! Before any application of the ERBE Kathalyse on patients with
a cardiac pacemaker, the cardiologist responsible for this patient should be
consulted in case of doubt in regard to risk for the patient.
Safety instructions for cryosurgery
WARNING! Dry nitrous oxide (N2O) in gas cylinders is recommended as a
refrigerant, which are stored vertically and must be secured against falling
over. The gas cylinders must be stored at room temperature, but never in the
proximity of a heat source. Only then work with the unit when both the unit
as well as the gas cylinder are at room temperature (18°C to 25°C). Room
temperature that is too low can interfere with the freezing capacity since the
gas pressure will then not reach the 40 bar value necessary for effective
operation.
7
Loading...