ERBECRYO 2 User Manual V1.0.x Feb 2014

User Manual

ERBECRYO® 2

Registered trademarks of ERBE Elektromedizin GmbH: APC®, APC 300®, AUTO CUT®, AUTOCUT®, BICISION®, BiClamp®, CLASSIC COAG®, CLASSIC CUT®, CLEVERCAP®, DeCo®, DRYCUT®, ENDO CUT®, ENDOCOAG®, ENDOCUT®, ERBE®, ERBE logo (design mark), ERBECRYO®, ERBEFLO®, ERBEJET®, ERBELift®, ERBOKRYO®, FIAPC®, FORCEDAPC®, Hybrid knife®, HybridKnife®, Hydro-Jet®, ICC 200®, ICC 80®, NESSY®, NESSY Ω®, PRECISE APC®, PRECISEAPC®, Preflow®, PULSEDAPC®, ReMode®, REMODE®, SWIFT COAG®, SWIFTCOAG®, The Color Blue®, TWIN COAG®, VIO®.

EN ISO 9001 EN ISO 13485 User Manual Art. No. 80113-401 Product Art. No. 10402-000 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 2014

Table of Contents

Table of Contents

1

Safety Instructions... 7 Normal use... 7 Intended Use... 7 Safety notations... 7 Meaning of the note... 7 Who must read this User Manual?... 8 Compliance with safety information... 8 Structure of safety instructions... 8 Operating errors and incorrect installation by persons without training... 8 Risks due to the environment... 9 Electric shock... 10 Risks due to operating errors... 11 Defective unit... 12 Risks due to instruments... 13 Risks due to unsuitable accessories... 13 Risks due to the gas bottle... 13 Risks due to gas... 15 Damage to the unit and accessories... 15 Notes... 15

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2

Safe handling of carbon dioxide and the gas bottle... 17 Safety instructions provided by the gas supplier, training... 17 Properties of carbon dioxide... 17 Transport and storage of the gas bottle, working with the gas bottle... 18

3

Description of the Controls... 21 Controls on the front panel... 21 Controls on the back... 22

4

Installation... 23 Ambient conditions... 23 Installing the unit on an ERBE equipment cart... 24 Connecting tubes and the footswitch... 24 Connecting the gas bottle to the gas cylinder connection... 26 Connecting gas bottles with the switching valve... 28 Changing the gas bottle (when using a gas cylinder connection)... 30 Changing gas bottles (when using a switching valve)... 31 Switching between two gas bottles using the switching valve... 31 Electrical connection... 32

5

Working with ERBECRYO 2... 35 Putting the gas bottle into operation... 35 Switching on, self-test... 35 Instrument connection, main screen... 36 Setting the effect, setting the timer... 37 Freezing, thawing... 39

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Table of Contents

Selecting a program... 40 Saving a program... 40 Overwriting a program... 43 Deleting a program... 44 Calling up information on the instrument... 45 Checking input pressure... 46 Calling up setup... 47 Bleeding the cryosystem off after use... 48 Disassembling the unit... 49

6

Cleaning and Disinfection... 51 Wipe disinfection... 51 Instructions for cleaning and disinfection... 51 Safety Instructions... 51

7

Status Messages, Error Messages... 53 Error messages on a blue screen... 53 Status messages... 53 Error messages... 54

8

Technical Data... 59

9

Information on electromagnetic compatibility (EMC)... 61

Maintenance... 65 Customer service... 65 Warranty... 65 Disposal... 66

11 Accessories... 67 Introduction... 67 ERBECRYO 2 example accessories... 68

Index... 69

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10 Maintenance, Customer Service, Warranty, Disposal... 65

1 • Safety Instructions

CHAPTER 1

Safety Instructions

Normal use The ERBECRYO 2 is intended for cryosurgery and cryotherapy. The exact use is determined by the instrument connected in each case. The ERBECRYO 2 may only be operated in rooms used for medical purposes and with CO2 (carbon dioxide).

Intended Use The cryosurgical unit is intended for cryoadhesion and cryodevitalization. The precise purpose is defined by the respective instrument connected.

Safety notations

DANGER

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indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE indicates a potentially hazardous situation which, if not avoided, may result in property damage.

Meaning of the note "Note:" Refers a) to manufacturer's information that relates directly or indirectly to the safety of people or protection of property. The information does not relate directly to a risk or dangerous situation. Refers b) to manufacturer's information that is important or useful for operating or servicing the unit.

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1 • Safety Instructions

Who must read this User Manual? Knowledge of the User Manual is absolutely essential for correct operation of the unit. The User Manual must therefore be read by everyone who works with the equipment. Anyone who prepares, sets, disassembles, cleans and disinfects the unit must also read the User Manual. Please pay particular attention to the safety instructions in each chapter.

Compliance with safety information Working with medical equipment is associated with certain risks to patients, medical personnel and the environment. Risks cannot be entirely eliminated by design measures alone. Safety does not depend solely on the equipment. Safety depends to a large extent on the training of medical personnel and correct operation of the equipment. The safety instructions in this chapter must be read, understood and applied by everyone who is working with the equipment.

Structure of safety instructions The safety instructions are structured according to the following risks: • Operating errors and incorrect installation by persons without training

• Electric shock • Risks due to operating errors • Defective unit • Risks due to instruments • Risks due to unsuitable accessories • Risks due to the environment • Risks due to gas • Damage to the unit and accessories • Notes

Operating errors and incorrect installation by persons without training

WARNING Operating errors and incorrect installation by persons without training Persons without training can operate or install the unit incorrectly. Risk of injury or death for patients and medical staff! Risk of damage to property.

 The equipment may only be used and installed by persons who have been trained on how to use and install it properly according to this User Manual.

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• Risks due to the environment

1 • Safety Instructions

 Training may only be carried out by persons who are suitable on the basis of their knowledge and practical experience.  In the event of uncertainties or if you have any questions, please contact ERBE Elektromedizin. You will find the addresses in the address list at the end of this User Manual.

Risks due to the environment

WARNING Ignition of combustible anesthetics, skin cleansers, or disinfectants If you use the unit in the presence of combustible anesthetics, skin cleansers, or disinfectants, these substances could ignite. Risk of fire and explosion to the patient and medical personnel! Danger of material damage.

 Do not use the unit in the presence of combustible anesthetics, skin cleansers, or disinfectants.

NOTICE Interference with the unit by portable and mobile HF communication devices (e.g. mobile phones, WLAN equipment) Electromagnetic waves emitted by portable and mobile HF communication devices can effect the unit.

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The unit may fail or not perform properly.

 Please see the table "Recommended separation distances between portable and mobile HF communications equipment and the equipment" at the end of this User Manual.

NOTICE Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity, it may sustain damage, fail, or not perform properly.

 Operate the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  If other ambient conditions must be observed for operation of the equipment, you will also find them in the Technical Data.

NOTICE Unsuitable temperature or humidity in transit or storage If you transport or store the equipment at an unsuitable temperature or level of humidity, it may sustain damage and fail.

 Transport and store the equipment at a suitable temperature and level of humidity. You will find the tolerances for temperature and humidity in the Technical Data.  If other ambient conditions must be observed for transport and storage of the equipment, you will also find them in the Technical Data.

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1 • Safety Instructions

NOTICE Insufficient acclimatization time, unsuitable temperature during acclimatization If the device was stored or transported below or above a certain temperature, it will take a certain time and temperature to acclimatize. If you do not observe the rules, the device can sustain damage and fail.

 Acclimatize the device according to the rules in the Technical Data.  Do not place the CO2 bottle close to a heat source. Heaters or air conditioners are examples of heat sources. Do not actively heat the CO2 bottle, e.g. using a fan heater. Do not expose the CO2 bottle to direct sunlight.

NOTICE Overheating of the device due to poor ventilation If ventilation is poor, the device can overheat, sustain damage, and fail.

 Install the device in such a way that there is an unobstructed circulation of air around the housing. Installation in confined wall recesses is prohibited.

 Make sure no liquid can penetrate the device.  Ensure that liquid does not penetrate through the instrument socket.  Do not place vessels containing liquids on top of the device.

Electric shock

WARNING Defective grounded power outlet, power supply network without proper grounding, inferior-quality power cord, incorrect line voltage, multiple power outlets, extension cords Risk of electric shock and other injuries to the patient and medical personnel! Risk of damage to property.

 Connect the unit / the equipment cart to a properly installed grounded power outlet.  Only connect the unit to a power supply network with proper grounding.  Only use the ERBE power cord or an equivalent power cord for this purpose. The power cord must bear the applicable national test symbol.  Check the power cord for damage. You must not use a damaged power cord.

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NOTICE Penetration of liquid into the device The housing is not absolutely watertight. If liquid penetrates, the device can sustain damage and fail.

1 • Safety Instructions

 The supply voltage must match the voltage specified on the unit's rating plate.  Do not use multiple power outlets.  Do not use extension cords.

WARNING Incorrect line fuse, defective device Risk of electric shock to the patient and medical personnel! Risk of damage to property.

 Blown line fuses may only be replaced by a competent technician. Only replacement fuses that have the same rating as the one specified on the unit’s rating plate may be used.  When a fuse has been changed, the function of the unit must be verified. If the unit does not function properly or if there are any concerns, please contact ERBE.

WARNING Connection of unit / equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel!

 Switch off the unit. Unplug the power cord of the unit.

Risks due to operating errors

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WARNING Activation of the unit with no knowledge of active settings If the user does not understand the active settings of the unit, he can cause the patient accidental tissue damage.

 Check the active settings on the display of the unit, after: switching on the unit, connecting an instrument, changing a program, and changing an effect.

CAUTION No activation signal, activation signal too quiet You do not hear when the unit is active. The user can cause the patient accidental tissue damage.

 Where possible, adjust the activation signal so that it is clearly audible.

WARNING The unit does not have a feature for restricting cryolesion. Risk of accidental tissue damage due to inattentiveness.

 Check the size of the cryolesion. Make sure you do not damage any healthy tissue. Stop the activation in good time.

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1 • Safety Instructions

WARNING Kinking or trapping the waste gas tube Increased pressure can damage the instrument head and instrument tube. Danger of injury to patient and medical personnel.

 Do not kink the waste gas tube. Do not stand on the waste gas tube.

WARNING Freezing in the immediate vicinity of cardiac pacemakers, internal defibrillators, or other active implants Risk of malfunction or of permanent damage to the active implants.

 Do not perform freezing in the immediate vicinity of active implants.

Defective unit

WARNING Damaged device or damaged accessories, modified device or accessories Danger of injury for patient and medical personnel! Danger of material damage.

 Check the gas connection, waste gas nozzle and instrument connection in particular for damage.  You must not use damaged equipment or damaged accessories. Replace defective accessories.  Close the bottle valve if unwanted freezing or leakage occurs.  If the unit or accessories are damaged, please contact Technical Service.  For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will invalidate liability on the part of ERBE Elektromedizin GmbH.

WARNING Technical safety checks not being done Risk of injury or death for patients and medical staff! Risk of damage to property.

 Have the device checked for safety at least once a year.  You must not use a device that is not safe.

WARNING Failure of display elements If display elements fail, you can no longer operate the device safely. Risk of injury or death for patients and medical staff!

 You must not use the unit.

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 Check the unit and accessories for damage every time before using them (e.g. footswitch, instruments, instrument tubes, gas hose, equipment cart).

1 • Safety Instructions

Risks due to instruments

CAUTION The instrument connector is not correctly inserted in the instrument connection of the unit. When the unit is activated, the connector may be pushed out. Danger of injury to patient and medical personnel.

 Make sure that the connector snaps into place when it is inserted.

CAUTION The cryoconnector is unplugged from the instrument socket during freezing, thawing or bleed-off. Danger of injury to patient and medical personnel.

 Do not unplug the cryoconnector from the instrument socket during freezing, thawing or bleed-off.

WARNING Damaged, leaky instrument CO2 can flow in an uncontrolled fashion and at high pressure into the patient's body. Risk of a gas embolism. Risk of death for the patient.

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 Do not bend rigid instruments. Do not kink flexible instruments. Do not apply mechanical force to the instruments.  Before each use, complete a visual check of the instrument and the instrument tube for mechanical damage. The instrument tube must not show any signs of abrasion. The rigid instrument must not be bent.  Before each use, check the instrument function and seal. The check is described in the instructions for use of the instrument. The check is mandatory before each use!  You must not use a damaged, leaky instrument!

Risks due to unsuitable accessories

CAUTION Using unsuitable accessories Danger of injury to patient and medical personnel.

 Only use ERBE instruments, footswitches, waste gas tubes, gas hoses and gas cylinder connections.

Risks due to the gas bottle

WARNING Damage to the gas bottle, to the valve. Gas escapes at high pressure. If the gas bottle has been weakened due to serious damage, this can lead to cracks in the wall of the bottle. Considerable stresses and

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1 • Safety Instructions

strains occur at the cracks, causing the bottle to break open. Gas emerges at high pressure. The gas bottle is propelled like a rocket. Risk of injury or death for patients and medical staff! Risk of damage to property.

 Do not apply force to gas bottles, bottle connectors and valves.  When transporting, storing, and using the gas bottle, prevent it from falling over and dropping by securing it with chains, hoops, or retaining straps.  Only transport gas bottles with the valve guard fitted: bottle cap or bottle collar.  Operate and store the CO2 bottle upright.  Do not place the CO2 bottle close to a heat source. Heaters or air conditioners are examples of heat sources. Do not actively heat the CO2 bottle, e.g. using a fan heater. Do not expose the CO2 bottle to direct sunlight.  Observe the safety instructions provided by the gas supplier.

WARNING Gas pressure too high Risk of accidental tissue damage due to unnecessarily severe or unwanted freezing. Increased pressure can damage the instrument head and instrument tube.

 Do not place the CO2 bottle close to a heat source. Heaters or air conditioners are examples of heat sources. Do not actively heat the CO2 bottle, e.g. using a fan heater. Do not expose the CO2 bottle to direct sunlight.  Operate and store the CO2 bottle upright.  Close the bottle valve, use a different gas bottle or allow the gas bottle to cool in a location under 25 °C.  If the error message continues to appear after these measures have been implemented, close the bottle valve and inform Technical Service. The device is defective. You must not use a defective device. Low pressure in the gas bottle

Note: If you operate the CO2 bottle at a room temperature below 15 °C, the bottle pressure and the flow of CO2 will be too low. The unit can no longer operate at full power. Work at a room temperature above 15 °C. Low pressure may also indicate that the gas bottle is empty.

CAUTION CO2 bottle with dip tube, horizontal CO2 bottle Liquid CO2 escapes. Pressure in the unit is too high. The unit can be damaged. Medical personnel and the patient could be injured by flying parts.

 Do not use a CO2 bottle with a dip tube.  Operate the CO2 bottle upright.

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An acoustic signal and a warning are output. Excessive gas pressure can be caused by an equipment fault, or if the gas bottle is too warm or too full.

1 • Safety Instructions

Risks due to gas

WARNING Dangerous CO2 concentration in room A high concentration of CO2 in the air can cause suffocation. CO2 is heavier than air. If discharge is not controlled, dangerous accumulations can develop close to the ground. Observe the national regulations regarding concentrations of CO2 permitted in the workplace.

 Connect the ERBE waste gas tube to the waste gas nozzle on the unit. Direct the waste gas into the anesthetic suction system or the open air. This procedure is recommended particularly where activation takes longer.  If it is not possible to use the ERBE waste gas tube, ensure that the room is adequately ventilated: enable air to circulate by opening windows and doors or by switching on the air conditioner.  Check the seal of all connections once the bottle valve has been opened. No gas may escape. If there are leaks, check that all connections are secure. If you cannot rectify the leak, close the bottle valve and inform Technical Service.

CAUTION Wrong gas e.g. N2O, Argon Risk of accidental tissue damage due to uncontrolled cooling with N2O. 80113-401 02.14

Risk of damage to the health of the patient and medical personnel if N2O is inhaled. Pressure in the system is too high. The unit can be damaged. Medical personnel and the patient could be injured by flying parts.

 Only use CO2. Observe the label on the gas bottle.

Damage to the unit and accessories

NOTICE Alcohol-based spray disinfectant for fast disinfection With membrane keyboards and paint surfaces there is the risk of cracks. Propanol and ethanol will erode surfaces.

 Do not use these substances.

NOTICE Alternate use of disinfectant solutions based on different active ingredients A color reaction may occur with plastics.

 Do not use these substances alternately.

Notes Grounding

Note: If necessary, the equipment can be connected to the external grounding system of the room with the grounding pin on the back of the unit and/or Cart using a

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1 • Safety Instructions

connecting cable designed for this purpose. Affects of low frequency leakage currents due to a defective grounding system within the room may be eliminated through external grounding. Note: The equipment conforms to the requirements of Type CF and is protected against the effects of a defibrillator discharge.

Membrane keyboards

Note: If alcohol-based disinfectants are used on units with membrane keyboards, this remove the anti-glare finish. However, the user surfaces remain fully functional. This does not present a hazard.

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Use of a defibrillator

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2 • Safe handling of carbon dioxide and the gas bottle

CHAPTER 2

Safe handling of carbon dioxide and the gas bottle

Safety instructions provided by the gas supplier, training Due to its specific properties, handling CO2 requires particular caution and knowledge. Particular knowledge is also required when handling the gas bottle and accessories, such as the gas cylinder connection, gas hose, etc. The gas bottle may only be operated by trained personnel. You gas supplier provides safety data sheets and safety instructions for handling CO2 and the gas bottle. Read the nationally-applicable safety data sheets. The information varies from country to country. The ERBECRYO 2 User Manual can therefore only provide some basic information on the safe handling of carbon dioxide and the gas bottle.

Properties of carbon dioxide

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Knowledge of the properties of CO2 will help you to better understand and apply the dos and don'ts in this User Manual.

Chemical

CO2 is non-combustible. Combustion reactions are inhibited or completely suppressed by CO2.

Physical

CO2 is heavier than air and primarily flows downwards when flowing out of gas bottles. If ventilation is poor, CO2 accumulations can remain close to the ground for several hours. Correlation between the bottle pressure and room temperature In the gas bottle, CO2 is liquid under pressure. The pressure of the liquid depends on the temperature and is approx. 57 bar at 20 °C. At higher room temperatures, the pressure in the gas bottle rises. As the unit can only be operated with gas bottles with a pressure level that does not exceed particular limits, the room temperature should be between 15 °C and 25 °C. It is possible that these values may not be reached or may be exceeded for a short period, as the gas bottle only heats up or cools down slowly. Fill level of the gas bottle Even a gas bottle that is almost empty has approx. 57 bar at 20 °C. The fill level can therefore only be determined by weighing and not by measuring the pressure. Only operate and store gas bottles upright If you draw CO2 from the upright gas bottle, you will receive CO2 gas. When the bottle valve is opened, the pressure in the gas bottle falls. CO2 vaporizes from the liquid and flows out as gas. Liquid CO2 escapes from a horizontal gas bottle. Liquid CO2 can damage the unit. You may therefore only operate the gas bottle upright. Do not use bottles with dip tubes Bottles with dip tubes are explicitly labeled as such. They are fitted with an internal dip tube that extends from the bottle valve to just above the base of the bottle. They provide liquid CO2. Liquid CO2 can damage the unit. Do not use bottles with dip tubes with the unit.

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2 • Safe handling of carbon dioxide and the gas bottle

Physiological

CO2 is colorless and odorless with no particular taste. It cannot be perceived by the senses. If a person enters an accumulation of CO2, he will not realize the danger. CO2 is not poisonous. It is part of the air we breathe and is not harmful to health in low concentrations. Observe the national regulations regarding concentrations of CO2 permitted in the workplace.

Transport and storage of the gas bottle, working with the gas bottle The aim of handling the gas bottle correctly is to prevent the following risks: • Mechanical damage to the bottle body and bottle valve. • The gas bottle falling over • Excessive heating and thus an increase in pressure • Uncontrolled CO2 discharge • Confusion between other gases

Transport

Preparing the gas bottle for transport

 Protect yourself when transporting heavy gas bottles with safety shoes and gloves.  Close the bottle valve.  Remove the gas cylinder connection.  If the gas bottle does not have a bottle collar, screw on a cylinder cap to protect the bottle valve.  Check that the cylinder cap and bottle collar are secure.

 Use suitable aids when transporting gas bottles, e.g. a bottle cart. Storage

Generally, specific requirements apply for the storage of gas bottles. Inform yourself of the regulations in your country. Generally, the following must be observed:

 Store the gas bottle upright with the bottle valve closed, using retaining straps, chains, etc. to prevent it from falling over, in a well-ventilated location at a temperature below 50 °C.  Do not expose the gas bottle to direct sunlight.  Do not place the gas bottle on a heater or in the immediate vicinity of an air conditioner.  Do not store the gas bottle in critical areas such as in corridors, recreation rooms, break rooms and along escape routes Working with the gas bottle

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 Make sure that the gas bottle contains CO2. Check the label on the gas bottle.  The gas bottle may only be operated upright. Secure the gas bottle using retaining straps, chains, etc. to prevent it from falling over.  If you have stored the gas bottle at below 15 °C or over 25 °C, allow the gas bottle to acclimatize at room temperature for 8 hours. Do not actively heat the gas bottle, e.g. using a fan heater.  Do not place the gas bottle on a heater or in the immediate vicinity of an air conditioner.  The room temperature should be between 15 °C and 25 °C. It is possible that these values may be exceeded or may not be reached for a short period, as the gas bottle only heats up or cools down slowly.  Check the thread of the bottle valve for damage.  Do not apply force to the gas bottle, gas cylinder connection and bottle valve.

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Transporting the gas bottle

2 • Safe handling of carbon dioxide and the gas bottle

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 Check the seal of all connections once the bottle valve has been opened. No gas may escape. If there are leaks, check that all connections are secure. If you cannot rectify the leak, close the bottle valve and inform Technical Service.  Close the bottle valve after every period of use.

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2 • Safe handling of carbon dioxide and the gas bottle

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3 • Description of the Controls

CHAPTER 3

Description of the Controls

Controls on the front panel

4 L1

R1

L2

R2

L3

R3

1

2 3

Fig. 3-1

Symbol

(1) Read the user manual before switching on and using the unit.

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Power

(2) Power switch Unit on / off. The unit is completely disconnected from the power supply only when the power connector is unplugged.

Selection buttons

(L1) (L2) (L3) (R1) (R2) (R3) The buttons have a different function depending on which window is shown on the display. Take note of the function the button refers to.

Symbol

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

Instrument receptacle

(4) Instrument receptacle (applied part) For connecting the instruments to the unit.

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