ATMOS®
S 61 Servant
instruments
GA1GB.110103.0
2017-10 Index: 24
Operating Instructions
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 certied 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
Specication of the main function:
ATMOS® S 61 Servant instruments:
• Instrument deposit and heating
• Storage room for examination and therapy devices
User prole: 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.
4
!
■
●
→
~
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 conguration in assembly of country-specic
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 specied 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
7
3.0 Connecting conditions
First start-up
Prior to shipment each ATMOS® S 61 Servant instruments is being inspected by the manufacturer for function and safety. In order
to make sure that the appliance is working safely after transport and installation, the following points should be observed: The user
should put the appliance into operation only if
1. a functional test on the appliance at the place of operation has been carried out.
2. the operating instructions have been read and noticed.
Following transportation at low temperatures the appliance must be held for up to fours hours at ambient temperature before rst
start-up. When the appliance has not been acclimatised the formation of condensation water is possible and a malfunction might be
the result.
i
3.1 Required connections for all units of ATMOS® S 61 Servant
Flexible multi-port distributors may not be used as a power supply for the ATMOS® S 61 Servant workstation, ATMOS® S 61
Servant vision or for an optional HF or radiofrequency surgical device.
Unit / Device Maximum required connections
ATMOS® S 61 Servant ENT workstation 1 x earthing contact socket outlet
ATMOS® S 61 Servant vision 1 x earthing contact socket outlet (basic version) or
1 x xed connection for the integrated camera or stroboscope LED
ATMOS® S 61 Servant instruments 3 x earthing contact socket outlet
Water separating system (WTA) 1 x earthing contact socket outlet
Monitor 1 x earthing contact socket outlet
Patient chair 1 x earthing contact socket outlet
An adequate number of socket outlets with earthing contact should be mounted for possible connection of further
electrically operated units which may be installed (e.g. installation of an electrically operated ATMOS® patient chair,
water separating system, camera, monitor, etc.)
3.2 Connection to electrical power line
Prerequisites
• Installation acc. to IEC 60346-7-710: earth leakage circuit breaker (FI-circuit breaker) with rated leakage current <0.03 A
• Connection of the power supply cable of the ATMOS® S 61 Servant instruments to a safety socket outlet near the device, max. 3
meters, preferably left (g.).
• The supply circuit must be separated from other devices e.g. PCs etc.
• If isolating transformers are used then isolation monitoring must be integrated in the isolating transformer.
• Maximum power consumption:
- ATMOS® S 61 Servant workstation 2.300 VA
- ATMOS® S 61 Servant vision 200 VA
- ATMOS® S 61 Servant instruments 250 VA
Flexible multi-port distributors may not be used as a power supply for the ATMOS® S 61 Servant vision or ATMOS® S 61 Servant
workstation.
Connect the unit to a mains socket with the supplied IEC power connector. Please observe country-specic voltage!
The ATMOS® S 61 Servant instruments has no mains switch for switching on the devices. Each optional available electrical device
has its own mains switch.
For separation from the power supply please disconnect the power plug!
i
8
4.0 Operation
Roller-shutter cover with lock Heated drawer
For switching on/off the heating,
please pull out the drawer fully
and operate the on/off switch in
the rear of the drawer.
Mirror pre-heating
The heated mirror magazine
has space for approx. 70 mirrors
(size K2 to K7). In order to
prevent the mirrors from fogging,
the magazine is pre-heated to
body temperature (38°C).
Switch on the mirror pre-heater
at the separate lateral power
switch.
Deposit for used instruments
To be lled / emptied
Retractable writing surface
When pulling out the writing
surface, please note that it has a
stop position.
Waste bin
Tip with your foot to open.
Insert a waste bag.
Insertable shelf for keyboard
For safe storage of a wireless PC
keyboard.
Drawer without cover
Height x width: 134 mm x
283 mm
E.g. for ATMOS® RS 221
Radiofrequency surgery. Observe
the notes in the operating
instructions which are delivered
separately.
9
5.0 Cleaning and care
) The described action relating to cleaning and disinfection
resp. sterilisation do not substitute the relevant
instructions which must be adhered to prior to operation!
• For disinfection, you may use all surface and instrument
disinfectants listed on page 10.
• Please take care that all surfaces are dry wiped. Use a
single-use cloth to absorb any liquid.
• In case that any disinfectant is spilled, please take care
to dry wipe the surface immediately in order that no liquid
may penetrate gaps and edges.
• The surfaces of the ATMOS® S 61 Servant instruments
are resistant against all surface disinfectants listed in on
page 11.
• Wipe the unit surface with a cloth moistened with a
cleaning or disinfecting solution.
• You may also use disinfectant sprays or disinfectant
tissues for cleaning and disinfection.
ª Please note that the alcohol contained in these
agents could corrode or cloud the protective covers if
employed on a long term basis.
) Always observe the concentration specications and
instructions by the respective manufacturer!
• Do not use
- Disinfectants which contain organic or inorganic acids
or bases as they could cause corrosion damage.
- Disinfectants containing chloramides or phenol
derivatives, since these may cause stress cracks in
the material used for the housing of the unit.
5.1.1 Cleaning the unit surface 5.1.2 Instrument trays
• Only deposit clean instruments on the board!
• Clean and disinfect the instruments regularly!
• Before disinfection, thoroughly rinse the trays under
running water. A detergent or cleaning agent (surface
disinfectant) may also be used if required.
- Use water to thoroughly rinse all residues of these
substances.
• Melamine and anodized aluminium trays cannot be
sterilised.
5.1 General information on cleaning and disinfection
Prior to cleaning
Set main switch of the ATMOS® S 61 Servant instruments to OFF prior to cleaning and disinfection!
Prior to each use:
if required
10
5.0 Cleaning and care
5.2 Recommended instrument disinfectants
Manual disinfection of instruments
Disinfectant Ingredients in 100 g Manufacturer
Korsolex® med AF
(Application concentrate)
N-dodecylpropane-1,3-diamine
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
surfactants, corrosion inhibitors, ph-value regulators, foam
inhibitors
15.6 g
5.1 g
Bode Chemie,
Hamburg
Korsolex® basic
(Application concentrate)
glutaral
(ethylenedioxy)dimethanol
surfactants, salts, corrosion inhibitors
15.2 g
19.7 g
Bode Chemie,
Hamburg
Korsolex® plus
(Application concentrate)
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
didecyldimethylammonium chloride
surfactants, corrosion inhibitors, complexing agents, ph-value
regulators
9.2 g
13.0 g
Bode Chemie,
Hamburg
Korsolex® extra
(Application concentrate)
(ethylendioxy)dimethanol
glutaral
benzyl-C12-18-alkyldimethyl-ammonium chlorides
didecyldimethylammonium chloride
surfactants, foam inhibitors, corrosion inhibitors
15.3 g
7.5 g
1.0 g
1.0 g
Bode Chemie,
Hamburg
neodisher® Septo MED
(Application concentrate)
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
didecyldimethylammonium chloride
non-ionic surfactants, perfumes
9.2 g
13.0 g
Dr. Weigert,
Hamburg
neodisher® Septo 3000
(Application concentrate)
glutaral
(ethylenedioxy)dimethanol
15.2 g
19.7 g
Dr. Weigert,
Hamburg
Sekusept® PLUS
(Application concentrate)
glucoprotamin 25 g Ecolab, Düsseldorf
Sekusept® aktiv
(Application concentrate)
sodiumpercarbonate, non-ionic surfactants, phosphonates Ecolab, Düsseldorf
Gigasept® Instru AF
(Application concentrate)
Cocospropylendiaminguanidindiacetate
Phenoxypropanols
Benzalkonium chloride
non-ionic surfactants, ph-value regulators, corrosion inhibitors
14 g
35 g
2.5 g
Schülke & Mayr,
Norderstedt
Gigasept® FF (new)
(Application concentrate)
succindialdehyde
dimethoxytetrahydrofuran
anionic and non-ionic surfactants, perfumes, methylisothiazolinone
11.9 g
3.2 g
Schülke & Mayr,
Norderstedt
Gigazyme®
(Application concentrate)
non-ionic surfactants, enzymes, corrosion inhibitors 5 - 15 g Schülke & Mayr,
Norderstedt
Automatic disinfection of instruments
Disinfectant Ingredients in 100 g Manufacturer
Dismoclean® 24 Vario
(Application concentrate)
surfactants, micro-encapsulated enzymes, corrosion inhibitors,
complexing agents
Bode Chemie,
Hamburg
Dismoclean® 28 alka med
(Application concentrate)
alkali dispenser, complexing agents, corrosion inhibitors, surface
active materials
Bode Chemie,
Hamburg
Dismoclean® twin basic /
twin zyme
Bode Chemie,
Hamburg
Dismoclean® twin basic alkali dispenser, complexing agents, corrosion inhibitors
Dismoclean® twin zyme surface active materials, enzymes, stabilisers, corrosion inhibitors
neodisher® FA Phosphates 15 - 30 g Dr. Weigert,
Hamburg
neodisher® MediClean forte
(Application concentrate)
non-ionic and anionic surfactants
enzymes
< 5 g Dr. Weigert,
Hamburg
Thermosept® alka clean
forte
(Application concentrate)
non-ionic surfactants
anionic surfactants
NTA (nitrilotriacetic acid) and its salts
enzymes, poly carboxylates
corrosion inhibitors
< 5 g
< 5 g
< 5 g
< 5 g
Schülke & Mayr,
Norderstedt
Thermosept® RKN-zym non-ionic surfactants, enzymes, corrosion inhibitors, glycols 5 - 15 g Schülke & Mayr,
Norderstedt
11
5.3 Recommended surface disinfectants
Coated surfaces
Disinfectant Ingredients in 100 g Manufacturer
Green & Clean SK Di alkyl dimethyl ammonium chloride
Alkyl dimethyl ethyl benzyl ammonium chloride
Alkyl dimethyl benzyl ammonium chloride
< 1 g
< 1 g
< 1 g
Metasys, Rum
(Austria)
Dismozon® pur
(Granulate)
End of product 12/2014
magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie,
Hamburg
Dismozon® plus
(Granulate)
magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie,
Hamburg
Kohrsolin® FF
(Application concentrate)
glutaral
benzyl-C12-18-alkyldimethyl-ammonium chlorides
didecyldimethylammonium chloride
5 g
3 g
3 g
Bode Chemie,
Hamburg
Perform
®
Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr,
Norderstedt
Terralin® Protect
(Application concentrate)
benzyl-C12-16 alkyldimethyl, chloride
2-phenoxyethanol
aminoalkylglycine
non-ionic surfactants, perfumes
22 g
17 g
0.9 g
Schülke & Mayr,
Norderstedt
Other surfaces
Disinfectant Ingredients in 100 g Manufacturer
Dismozon® pur
(Granulate)
End of product 12/2014
magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie,
Hamburg
Dismozon® plus
(Granulate)
magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie,
Hamburg
Kohrsolin® FF
(Application concentrate)
glutaral
benzyl-C12-18-alkyldimethyl-ammonium chlorides
didecyldimethylammonium chloride
5 g
3 g
3 g
Bode Chemie,
Hamburg
Mikrobac® forte
(Application concentrate)
benzyl-C12-18-alkyldimethyl-ammonium chlorides 19.9 g Bode Chemie,
Hamburg
N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine 5 g
Perform
®
Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr,
Norderstedt
Terralin® Protect
(Application concentrate)
benzyl-C12-16 alkyldimethyl, chloride
2-phenoxyethanol
aminoalkylglycine
non-ionic surfactants, perfumes
22 g
17 g
0.9 g
Schülke & Mayr,
Norderstedt
Surface disinfection F
312
alkyl-benzyl-dimethyl-ammonium chloride
non-ionic surfactants, complexing agents, hexyl cinnamal, butyl
phenyl methyl proionale, linalool
13 g Dürr Dental,
BietigheimBissingen
When using disinfectants containing aldehyde and amine at the same object colour changes may occur.
5.0 Cleaning and care
12
5.4 Recommended endoscope disinfectants
Manual disinfection of endoscopes
Disinfectant Ingredients in 100 g Manufacturer
Helipur® H plus N glutaral
2-propanol
ethyl hexanol
surfactants, complexing agents, corrosion inhibitors, colorants,
perfumes
12 g
7.5 g
0.5 g
BBraun,
Melsungen
Helix® Ultra peracetic acid BBraun,
Melsungen
Korsolex® basic glutaral
(ethylendioxy) dimethanol
surfactants, salts, corrosion inhibitors
15.2 g
19.7 g
Bode Chemie,
Hamburg
neodisher® MediClean forte
(Application concentrate)
non-ionic and anionic surfactants
enzymes
< 5 g Dr. Weigert,
Hamburg
Sekusept® aktiv
(Application concentrate)
sodiumpercarbonate, non-ionic surfactants, phosphonates Ecolab,
Düsseldorf
Automatic disinfection of endoscopes
Disinfectant Ingredients in 100 g Manufacturer
Korsolex® basic glutaral
(ethylendioxy) dimethanol
surfactants, salts, corrosion inhibitors
15.2 g
19.7 g
Bode Chemie,
Hamburg
neodisher® MediClean forte
(Application concentrate)
non-ionic and anionic surfactants
enzymes
< 5 g Dr. Weigert,
Hamburg
Gigasept® FF (new)
(Application concentrate)
succindialdehyde
dimethoxytetrahydrofuran
anionic and non-ionic surfactants, perfumes,
methylisothiazolinone
11.9 g
3.2 g
Schülke
& Mayr,
Norderstedt
Endozime® AW Plus 2-propanol Ruhof,
Mineola
(USA)
Adaptaclean
TM
Potassium hydroxide, surfactants ASP,
Norderstedt
5.0 Cleaning and care
13
What How
Recommendations
When Who
Reusable parts
C
CleaningDDisinfectionSSterilisation
After each
procedure
Weekly
Monthly
Qualifi ed and trained
staff who are familiar
with reprocessing.
(Please fi ll in the
responsible person
-> use a water-based
overhead marker)
Daily
Secretion canister
Hose connection (nozzle)
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Suction lid
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Gasket
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Bacterial fi lter Daily exchange or when fi lter is blocked
X
Splash protection
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Float ball
X X
Cleaning and disinfection (automatic or manual)
X
Suction hose in the
canister
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Secretion canister
X X
Empty when the canister is full; at least daily
Cleaning and disinfection (automatic or manual)
X
Disposable canister
system
Exchange and disposal of full canister
X
Hose irrigation system
Suction nozzle
for hose irrigation
X X
3
Wipe cleaning and disinfection
X
Silicone attachment piece
X X
2,4,5,6
Cleaning and disinfection (automatic or manual)
X
Exchange of the Silicone attachment
X
Suction nipple
X
Manual cleaning after each patient
X
X
2,4,5,6
Manual or automatic cleaning and disinfection
X
Secretion suction hose
X
Rinse the secretion hose with the hose irrigation
system after each procedure;
X
X
2,4,5,6
Exchange or disinfection of the hose
X
Storage canister for
hose irrigation system
X X
2,4,5,6
Cleaning with a brush; Manual or automatic cleaning and
disinfection
X
Ear irrigation / Thermal nystagmus stimulation
Ear irrigation bowl
X X
2,4,5
Manual or automatic cleaning and disinfection
X
Handle
X X
3
Wipe cleaning and wipe disinfection
X
Jet connection
X X
2,4,5,6
Manual or automatic cleaning and disinfection
X
Splash protection
X X
2,4,5
Cleaning and disinfection (automatic or manual)
X
Hose tip (disposable) Exchange after each application
X
Rinsing attachment
X X
2,4,5
Manual or automatic cleaning and disinfection
X
Hygiene fi lter See operating instructions for hygiene fi lter
X
Rinsing lid with rinsing
hose
X X
2,4,5
Manual or automatic cleaning and disinfection
X
Rinsing bottle
X X
2,4,5,6
Cleaning and disinfection; cleaning in the dishwasher
with the glass care programme
X
Medication nebulisation / Politzer
Handle for
compressed air
X X
3
Manual cleaning and disinfection
X
Sprayer jet
X
Cleaning after each application
X
X
2,4,5,6
Manual or automatic cleaning and disinfection
X
Sprayer head
X
2,4,5
Multiple rinsing of the sprayer head with water
X
Hose at sprayer head
X X
Weekly exchange of the hose or when changing the
medication
X
Sprayer bottle
X X
2,4,5,6
Cleaning in a cleaning and disinfection device; weekly or
when changing the medication
X
Politzer olive
X X
2,4,5,6
Exchange after each application.
Cleaning and disinfection
X
Politzer connection
X X
2,4,5,6
Exchange after each application.
Cleaning and disinfection
X
Endoscope management
Plastic quiver
X X
2,4,5
Cleaning with a brush; disinfection
X
Metal quiver
X X
2,4,5,6
Cleaning with a brush; disinfection (automatic or manual)
X
Fixation adapter for
plastic quiver
X X
2,4,5
Manual or automatic cleaning and disinfection
X
Protective sleeve (tefl on
element for metal quiver)
X X
2,4,5
Manual or automatic cleaning and disinfection
X
Cleaning and disinfection plan
ATMOS
®
S 61 Servant
6.0 Hygiene Plan
14
6.0 Hygiene Plan
What How
Recommendations
When Who
Reusable partsCCleaningDDisinfectionSSterilisation
After each
procedure
Weekly
Monthly
Qualifi ed and trained
staff who are familiar
with reprocessing.
(Please fi ll in the re-
sponsible person ->
use a water-based
overhead marker)
Daily
Instrument management
ENT instruments
X X
2,4,5
X
Immerse instruments into solution immediately after use,
complete wetting is required, air must be removed from
any cavities, after the contact time instruments must be
rinsed with water, have to be dried and sterilised afterwards. Please also observe the ATMOS operating
instructions for ENT instruments.
X
Instrument bowl
X X
4
Cleaning and disinfection (manual)
X
Instrument bowl with cover
X X
4
Cleaning with a brush; afterwards disinfection (manual)
X
Visualisation
ATMOS® Cam 21 / 31
X X
3
Wipe cleaning and wipe disinfection
X
ATMOS® Strobo 21 LED
X X
3
Wipe cleaning and wipe disinfection
X
Flexible scope
X X
1,7,8
X
1)
Immediate pre-cleaning after the procedure
X
Rigid scope
X X
1,7,8
X
1)
Immediate pre-cleaning after the procedure
X
Laryngoscope
X X
1,7,8
X
1)
Immediate pre-cleaning after the procedure
X
Light conductor
X X
3
Wipe cleaning and wipe disinfection
X
Light grip
X X
3
Wipe cleaning and wipe disinfection
X
Microscope
X X
3
Wipe cleaning and wipe disinfection
X
Headlight
X X
3
Wipe cleaning and wipe disinfection
X
Radiofrequency surgery
ATMOS® RS 221 (surface)
X X
3
Wipe cleaning and wipe disinfection
X
Ergonomic handles
X X
1,2,4,5
X
1)
Wipe cleaning and wipe disinfection
X
Bipolar tweezers
X X
1,2,4,5
X
1)
Immediate pre-cleaning after the procedure
cleaning and disinfection (automatic or manual);
use of enzymatic detergents
X
Bipolar electrode
X X
1,2,4,5
X
1)
X
Bipolar electrode cable
X X
1,2,4,5
X
1)
Immediate pre-cleaning after the procedure
cleaning and disinfection (automatic or manual);
use of enzymatic detergents
X
Neutral electrode
X X
1,2,4,5
X
1)
X
Neutral electrode cable
X X
1,2,4,5
X
1)
Immediate pre-cleaning after the procedure
cleaning and disinfection (automatic or manual);
use of enzymatic detergents
X
ENT electrodes
X X
1,2,4,5
X
1)
X
Surfaces
Housing
X X
3
Wipe cleaning and wipe disinfection
X
Roller shutter
X X
3
Wipe cleaning and wipe disinfection
X
System frame
X X
3
Wipe cleaning and wipe disinfection
X
Drawers
X X
3
Wipe cleaning and wipe disinfection
X
Writing surface
X X
3
Wipe cleaning and wipe disinfection
X
Instrument deposit
X X
3
Wipe cleaning and wipe disinfection
X
Mirror pre-heater
X X
3
Wipe cleaning and wipe disinfection
X
Tongue patches and
swab dispenser
X X
3
Wipe cleaning and wipe disinfection,
every day or when refi lling
X
Waste disposal
X X
3
Wipe cleaning and wipe disinfection,
every day or when emptying the canister
X
Instrument tray
X X
3
Wipe cleaning and wipe disinfection, daily when replacing
with new instruments
X
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16 79853 Lenzkirch/Germany
Phone +49 7653 689-0 Fax +49 7653 689-190
atmos@atmosmed.de www.atmosmed.de
The above stated hygiene requirements are based on the regulations
according to the Medical Devices Act, the Medical Devices Operator
Ordinance, §18 IfSG and the recommendations of the Robert Koch
Institute.
Defi nition of the required reprocessing steps result from the recommendations of the Robert Koch Institute: „Requirements for
the reprocessing of medical products“. The medical products were
categorised in the risk groups uncritical, semicritical and critical. The
reprocessing measures mentioned in this cleaning and disinfection
plan are a recommendation of ATMOS MedizinTechnik. Any additio-
nal reprocessing measures are at the operator‘s discretion.
All the recommended disinfectants which are stated herein are listed
disinfectants (VAH/RKI) and have been tested on their suitability of
use on the ATMOS
®
S 61 Servant. ATMOS MedizinTechnik cannot
be hold liable for any damage caused by wrong concentration of the
disinfectants or by the application of any other disinfectants.
Patients with suspicion of a clinical disease or who developed a
transmissible spongiform encephalopathy (CJK, vCJK, etc.) have to
be treated at facilities which are able to provide for the necessary
preventive measures against infection. The reprocessing of the reusable instruments and material may only be performed at facilities
which have an externally certifi ed QM Management acc. to DIN EN
ISO 13485.
The Medical Devices Act, IfSG, the RKI directives, BGR 250 and
TRBA 250 always have to be considered.
Important information
Wipe cleaning and wipe disinfection: All surfaces have to be wiped with a clean (disposable) wipe which is damped with disinfectant
solution; the entire surface has to be wiped thoroughly and may not be dried afterwards.
1)
Please observe the manufacturer‘s operating instructions.
2)
Alternative to manual cleaning und disinfection: Wash-
Disinfector 78°C / 172°F
6)
Material dimensionally stable at 134°C
Wrong concentration of disinfectants
may lead to damage!
Recommended disinfectants
3)
Surface disinfection
for coated surfaces:
Green & Clean SK (ATMOS)
Dismozon
®
plus (Bode Chemie)
Kohrsolin
®
FF (Bode Chemie)
Perform
®
(Schülke & Mayr)
Terralin
®
Protect (Schülke & Mayr)
Other surfaces:
Dismozon
®
plus (Bode Chemie)
Kohrsolin
®
FF (Bode Chemie)
Mikrobac
®
forte (Bode Chemie)
Perform
®
(Schülke & Mayr)
Terralin
®
Protect (Schülke & Mayr)
Surface disinfection FD 312 (Dürr Dental)
4)
Instruments - manual disinfection:
Korsolex
®
med AF (Bode Chemie)
Korsolex
®
basic (Bode Chemie)
Korsolex
®
plus (Bode Chemie)
Korsolex
®
extra (Bode Chemie)
neodisher
®
Septo MED (Dr. Weigert)
neodisher
®
Septo 3000 (Dr. Weigert)
Sekusept
®
PLUS (Ecolab)
Sekusept
®
aktiv (Ecolab)
Gigasept
®
Instru AF (Schülke & Mayr)
Gigazyme
®
(Schülke & Mayr)
Gigasept FF neu (Schülke & Mayr)
5)
Instruments - automatic disinfection:
Dismoclean
®
24 Vario (Bode Chemie)
Dismoclean
®
28 alka med (Bode Chemie)
Dismoclean
®
twin basic/twin zyme (Bode Chemie)
neodisher
®
FA (Dr. Weigert)
neodisher
®
MediClean forte (Dr. Weigert)
Thermosept
®
alka clean forte (Schülke & Mayr)
Thermosept
®
RKN-zym (Schülke & Mayr)
7)
Endoscopes - manual disinfection:
Helipur
®
H plus N (BBraun)
Helix
®
Ultra (BBraun)
Korsolex
®
Basic (Bode Chemie)
neodisher
®
MediClean forte (Dr. Weigert)
Sekusept
®
aktiv (Ecolab)
8)
Endoscopes - automatic disinfection:
Korsolex
®
Basic (Bode Chemie)
neodisher
®
MediClean forte (Dr. Weigert)
Gigasept
®
FF neu (Schülke & Mayr)
Endozime
®
AW Plus (Ruhof)
ADAPTACLEAN™ (ASP)
Please see the manufacturer‘s instructions for
concentration, contact time, temperature and
the compatibility of materials.
GA3GB.110100.0 2017-05 Index: 13
15
7.0 Maintenance and Service
7.1 Replacing the fuse ATMOS® S 61 Servant instruments
7.2 Replacing the fuse heated drawer
Remove the fuse carrier beside the On/Off switch and exchange the fuse.
Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are
familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts.
ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing
are carried out professionally, original spare parts are used and warranty claims remain unaffected.
• At least every 12 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS
recommends an inspection according to the manufacturer‘s specications.
7.3 Sending in the device
• Remove and properly dispose of consumables.
• Clean and disinfect the product and accessories according to the operating instructions.
• Place used accessories with the product.
• Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certicate.
) This form is enclosed to each delivery and can be found at www.atmosmed.com.
• The device must be well padded and packed in suitable packaging.
• Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certicate in an envelope.
• Afx the envelope to the outside of the package.
• Send the product to ATMOS or to your dealer.
16
8.0 Technical data
Voltage 230 V~ ± 10 %; 50/60 Hz
Special voltage: 100-127 V~ ± 10 %; 50/60 Hz
relevant for single modules
Current consumption max. 2.5 A (230 V~); max. 5.8 A (100 V~)
Power consumption max. 580 VA
Fuses 2 x T 3.15 A (230 V)
2 x T 6.3 A (100 ... 127 V)
Drawer elements Suitable for ATMOS® Surgery devices or ATMOS® smoke evacuation
Mirror preheater Temperature of Instruments approx. 37 °C, heat output approx. 120 VA
Heated drawer Temperature of Instruments approx. 37 °C, heat output approx. 230 VA
Operating time Continuous operation
Protective earth conductor resistance max. 0.1 Ω
Earth leakage current max. 0.5 mA
Ambient conditions
Transport / storage -10...+50°C
30...95 % air humidity without condensation
at an air pressure of 500...1060 hPa
Operation +10...+35°C
30...95 % air humidity without condensation
at an air pressure of 700...1060 hPa
Dimensions HxWxD 88.5 x 41.2 x 54.0 cm
Weight 15-32 kg
Period tests Repeat test of the electrical safety every 12 months.
Recommended: inspection according to the manufacturer‘s specications.
Safety class (EN 60601-1) I
Type of protection IP X0
Classication in accordance with Appendix
IX EC Directive 93/42/EEC
I
CE marking CE
Applied standards EN 60601-1; EN 60601-1-2
UMDNS code 10-585 ENT treatment unit
GMDN code 11585
Ident No. 532.0000.0 Basic module;
532.0110.0 power supply module 230 V;
532.0111.0 power supply module 100 ... 127 V
• The ATMOS® S 61 Servant instruments does not contain any hazardous goods.
• The component parts of the ATMOS® S 61 Servant instruments must be disposed of correctly and the materials are to be
separated carefully.
• The materials of the housing can be recycled completely.
9.0 Disposal
17
10.0 Notes on EMC
10.1 Guidelines and Manufacturer´s Declaration - Emissions
The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specied below. The customer or
user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions acc.to CISPR 11 Group 1 The ATMOS® S 61 Servant instruments uses RF energy only
for its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby electronic
equipment.
RF Emissions according to CISPR 11Class B
The ATMOS® S 61 Servant instruments is suitable for use in all
establishments, including domestic, and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions according to
IEC 61000-3-2
Inapplicable
Voltage uctuations/icker according
to IEC 61000-3-3
Inapplicable
10.2 Guidelines and Manufacturer's Declaration - Immunity
The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specied below. The customer or
user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment.
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge
(ESD) according to IEC
61000-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood, concrete, or ceramic
tile. If oors are synthetic, the relative humidity
should be at least 30 %.
Fast electrical transient/
burst IEC 61000-4-4
± 2 kV Mains
± 1 kV I/Os
± 2 kV Mains
Inapplicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surges IEC 61000-4-5 ± 1 kV differential mode
± 1 kV common-mode
± 2 kV differential mode
± 1 kV common-mode
Mains power quality should be that of a typical
commercial or hospital environment.
Magnetic eld at power
frequency 50/60 Hz acc.
to IEC 61000-4-8
3 A/m Inapplicable Power frequency magnetic elds should be that
of a typical commercial or hospital environment.
• Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC
notes.
• Portable and mobile HF communication facilities can inuence medical electrical equipment.
• The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced
interference immunity of the equipment or system.
i
The device may not be used directly next to other devices or piled up with other devices. If operation next to or piled with other
devices is necessary, please watch the device to check its intended operation in this arrangement.
i
18
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Voltage Dips / Dropout
IEC 61000-4-11
< 5 % UT
(> 95 % Dip of the UT)
for 0,5 Cycles
40 % UT
60% Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
< 5 % UT
(> 95 % Dip of the UT)
for 0,5 Cycles
40 % UT
60% Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the ATMOS® S 61 Servant instruments
demands continued function even in case
of interruptions of the energy supply, it is
recommended to supply the ATMOS® S 61
Servant instruments from an uninterruptible
current supply or a battery.
NOTE UT is the mains alternating current prior to application of the test levels.
10.3 Guidelines and Manufacturer´s Declaration - Immunity
The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specied below. The customer or
user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment.
Immunity Test
IEC 60601- Test
Level
Compliance Level Electromagnetic Environment - Guidance
Conducted RF IEC
61000-4-6
3 V
eff
150 kHz to 80 MHz
3 V
eff
Portable and mobile communications equipment
should be separated from the ATMOS® S 61 Servant
instruments incl. the cables by no less than the
distances calculated/listed below.
Recommended distances:
d = (3.5 / V1) * √(P)
d = (3.5 / E1) * √(P) 80-800 MHz
d = (7 / E1) * √(P) 0.8-2.5 GHz
where „P“ is the max. power in watts (W) and d is the
recommended separation distance in meters (m).
Field strengths from xed transmitters, as determined by
an electromagnetic site (a) survey, should be less than
the compliance level (b).
Interference may occur in the vicinity of equipment
containing following symbol:
Radiated RF IEC
61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
10.0 Notes on EMC
19
10.4 Recommended safety distance between portable and mobile RF
Communications equipment and the ATMOS® S 61 Servant instruments
NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and
reection of buildings, objects and people.
The ATMOS® S 61 Servant instruments is intended for use in electromagnetic environment in which radiated disturbances are
controlled. The customer or user of the ATMOS® S 61 Servant instruments can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS® S 61 Servant
instruments as recommended below, according to the maximum output power of the communications equipment.
Safety distance, depending on transmit-frequency m
Nominal output of the
transmitter
W
150 kHz to 80 MHz
d = [ 3.5 / 3] √P
80 MHz to 800 MHz
d = [ 3.5 / 3] √P
800 MHz to 2.5 GHz
d = [ 7.0 / 3] √P
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.2 1.2 2.4
10 3.69 3.69 7.38
100 11.66 11.66 23.32
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended
safety distance d in meters (m) can be determined using the equation belonging to the respective column whereas
P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specication.
NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by
absorption and reection of buildings, objects and people.
a
The eld strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment,
amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic
environment in regard to stationary transmitters, a study of the location is to be considered. If the measured eld strength at the
location where the ATMOS® S 61 Servant instruments is used exceeds the above compliance level, the ATMOS® S 61 Servant
instruments is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures
might be necessary, e. g. a changed arrangement or another location for the device.
b
Within the frequency range of 150 kHz to 80 MHz the eld strength should be below 3 V/m.
10.0 Notes on EMC
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-370
atmos@atmosmed.de
www.atmosmed.com
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