Atmos S61 Servant Operating Instructions Manual

ATMOS® S 61 Servant instruments
GA1GB.110103.0
2017-10 Index: 24
English
2
Further information, accessories, consumables and spare parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Phone: +49 76 53 / 689-0
Fax: +49 76 53 / 689-190
+49 76 53 / 689-493 (Service Centre)
atmos@atmosmed.de
www.atmosmed.de
Table of contents
1.0 Introduction .........................................................3
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................3
1.3 Explanation of pictures and symbols ....................4
2.0 For your safety ....................................................5
3.0 Connecting conditions .......................................6
3.1 Required connections for all units of
ATMOS® S 61 Servant .........................................6
3.2 Connection to electrical power line .......................6
4.0 Operation .............................................................8
5.0 Cleaning and care ...............................................9
5.1 General information on cleaning and disinfection .9
5.1.1 Cleaning the unit surface ......................................9
5.1.2 Instrument trays ....................................................9
5.2 Recommended instrument disinfectants .............10
5.3 Recommended surface disinfectants .................. 11
5.4 Recommended endoscope disinfectants ............12
6.0 Hygiene plan ......................................................13
7.0 Maintenance and Service .................................15
7.1 Replacing the fuse ATMOS® S 61 Servant
instruments .........................................................15
7.2 Replacing the fuse heated drawer ......................15
7.3 Sending in the device..........................................15
8.0 Technical data ...................................................16
9.0 Disposal .............................................................16
10.0 Notes on EMC ....................................................17
3
1.2 Intended use
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® S 61 Servant instruments safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases, amongst other things, the reliability and service-life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Reprints (also in extracts) only with permission in written form by ATMOS.
These operating instructions must always be kept available near the device.
Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® S 61 Servant instruments and are therefore a must besides regular cleaning.
Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS® S 61 Servant instruments will be preserved.
• The product ATMOS® S 61 Servant instruments bears CE marking CE according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.
• The product ATMOS® S 61 Servant instruments complies with all applicable requirements of the Directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”).
• The declaration of conformity and our general standard terms and conditions can be obtained on our website at www.atmosmed.com.
The quality management system applied at ATMOS has been certied according to international standards EN ISO 13485.
• Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible dangerous situations.
Name: ATMOS® S 61 Servant instruments
Main functions:
ATMOS® S 61 Servant instruments:
• Instrument management
Medical indications / application:
Standard ENT examination and/or therapy
Specication of the main function:
ATMOS® S 61 Servant instruments:
• Instrument deposit and heating
• Storage room for examination and therapy devices
User prole: Doctors and medical assistants
Patient groups: Patients of all ages with and without restrictions
Application organ:
Mouth to pharynx, auditory canal to the ear drum and the nasal cavities
Application time:
• ENT unit: Short term use (up to 30 days)
• Suction / Compressed air / ear rinsing / light source: Temporary application on the patient (less than 60 minutes)
Application site:
Application sites are clinics and practices for ENT doctors and phoniatrists. The examination and/or therapy with the ENT unit may only be executed by medically trained persons.
Contraindications:
• May not be used for irrigation of the paranasal sinuses.
• The ear irrigation should not be applied to an infected auditory canal or a perforated eardrum.
The product is: active
Sterility:
The ENT unit is no sterile product.
Single-use product / reprocessing:
The ENT unit is intended for multiple use. The device and parts of the accessories are reusable. For information on reprocessing and disinfection, please see the operating instructions.
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1.3 Explanation of pictures and symbols
Icons on the product
Off (feed-in, power connection)
On (feed-in, power connection)
Alternating current
Ground wire connection
Warning, special diligent notice
Fuse according to IEC 417/5016, DIN 30600/0186
Potential equalisation
1.0 Introduction
Short cuts / symbols contained in these operating instructions
Please press where dot indicates
Subnumeration
Numeration
General information
Follow the arrows
Activate the optional foot switch
Replace
Check
Please read, important information
Move, plug... in this direction
Engage, check
correct t
Turn, shift ... in this direction
click
5
!
For your safety
2.0 For your safety
• The ATMOS® S 61 Servant instruments is produced according to IEC 601 / EN 60601 and listed in the following classes:
- VDE Class of protection 1
- Class IIa (EEC 93/42).
• The device may only be connected to a properly installed grounded electrical outlet.
Correct conguration in assembly of country-specic
connections: green/yellow: non-fused earth conductor (PE) blue: neutral conductor (N) black resp. brown: phase (L)
• Caution! Mirror and endoscope heaters may generate temperatures above 40°C!
• The ATMOS® S 61 Servant instruments may only be used under the supervision of skilled staff who have been authorised by ATMOS and trained in its operation (IEC 601-1 / EN 60601-1).
• The mains voltage indicated on the type plate must correspond to the values of the supply network.
• Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged leads and hoses must be replaced immediately!
• It is prohibited to simultaneously pull out several heavily laden instrument deposits.
• Never leave the patient unattended at the treatment unit.
• Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connected.
• Do not place used contaminated instruments on the ENT unit except on destined places!
The ambient conditions specied in the "Technical data" must be strictly observed!
• Switch off main switches of the installed devices after
nishing work in the practice.
• The ATMOS® S 61 Servant instruments may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments.
• The ATMOS® S 61 Servant instruments meets the immunity to interference requirements of IEC 601-1-2 / EN 60601-1-2 „Electromagnetic Compatibility – Medical Electrical Devices“.
• The ATMOS® S 61 Servant instruments may not be operated with devices not complying with the requirements of standard EN 60601-1 „Medical Electrical Equipment“ and EN 60601-1-2 „Electromagnetic Compatibility“ (Medical Electrical Equipment).
• ATMOS is not liable for personal injury and damage to property if
- no original ATMOS parts are being used,
- the advice for use in these operating instructions is not being observed,
- assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS.
• In order to fully disconnect the device from the mains supply the mains plug must be removed from the wall outlet.
• This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.
6
ca. 250
<150
160
>350
250
640
979,51961
1550
740
1730
730
630
2940
445
3.0 Connecting conditions
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