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GA - S61ServantENTWorkstation ATMOS
GA - S61ServantENTWorkstation ATMOS
ATMOS® S 61
Servant ENT
workstation
ENT treatment unit
Operating Instructions
0124
GA1GB.110101.0
2018-05 Index: 28
Table of contents
ATMOS
7.5 Hygrotherm / Variotherm: Filter replacement.......34
7.6 Sending in the device..........................................34
2
1.0 Introduction
• The product ATMOS® S 61 Servant ENT workstation bears CE marking CE 0124 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 ENT workstation 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 certified 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.
3
1.0 Introduction
Contraindications: Do not apply to an infected resp. Application site: In clinics and practices for ENT
contaminated auditory canal or to a doctors and phoniatricians. The
perforated eardrum. therapy with the ATMOS stimulation
and irrigation device may only be
The product is: active performed by medical trained staff.
Sterility: Not necessary Contraindications: Do not apply to an infected resp.
Single-use product No single use product contaminated auditory canal or to a
/ reprocessing: perforated eardrum.
The product is: active
Sterility: Not necessary
Single-use product No single use product
/ reprocessing:
1.3 Function
The treatment unit ATMOS® S 61 Servant ENT workstation makes modular assembly possible for the following functional
modules:
• Suction system
• Compressed-air system
• Ear irrigation module (Hygrotherm)
• System for thermal nystagmus stimulation
• LED light source LS 21 LED
• LED head light HL 21 LED
4
1.0 Introduction
Foot switch
5
2.0 For your safety
!
2.1 For your safety • Existing water consuming devices may only be switched
on when the water supply is guaranteed!
• The ATMOS® S 61 Servant ENT workstation is produced • The ENT unit requires clean water (drinking-water
according to IEC 601 / EN 60601 and listed in the quality) for the operation. In case the clean water cannot
following classes: be provided by the water supply, a pre-filter must be
-- VDE Class of protection 1 installed. The relevant country specific regulations for the
-- Class IIa (EEC 93/42). installation must be considered!
• The device may only be connected to a properly installed • Please note:
grounded electrical outlet. A medical insulating transformer with earth leakage
• Correct configuration in assembly of country-specific monitor or any similar safety system acc. to EN 60 601-1
connections: is required, if several devices are connected over one
-- green / yellow: protective conductor (PE) common power supply. The transformer must correspond
-- blue: neutral conductor (N) to the power consumption of all the devices to be
-- black or brown: phase (L) connected.
• Caution! Mirror and endoscope heaters may generate • Do not place used contaminated instruments on the ENT
temperatures above 40°C! unit except on destined places!
• The ATMOS® S 61 Servant ENT workstation may only • The ambient conditions specified in the "Technical data"
be used under the supervision of skilled staff who have must be strictly observed!
been authorised by ATMOS and trained in its operation • Switch off main switch after finishing work in practice and
(IEC 601-1 / EN 60601-1). close water supply, if present.
• The mains voltage indicated on the type plate must • Care is to be paid in respect to light sources when
correspond to the values of the supply network. working with endoscopes. Do not look directly into the
• Make sure prior to every application of the equipment that light outlets! In case of possible light failure remove the
it is technically safe and in proper condition. Damaged endoscope from the working area.
leads and hoses must be replaced immediately! • The ATMOS® S 61 Servant ENT workstation may be
• Display instruments and valves must be checked for operated only in rooms used for medical purposes, but
correct function at regular intervals! not in areas subject to explosion hazards and in oxygen
• Every morning a visual inspection of the hoses, secretion rich environments.
canister and cables must be performed. Exchange • The ATMOS® S 61 Servant ENT workstation meets the
damaged parts! Only proper and undamaged plugs and immunity to interference requirements of IEC 601-1-2 /
extension cables may be used. EN 60601-1-2 „Electromagnetic Compatibility – Medical
• Switch off the unit before you open it and separate it from Electrical Devices“.
the line voltage. • The ATMOS® S 61 Servant ENT workstation may
• Maximum load for clipboard: 2 kg! not be operated with devices not complying with the
requirements of standard EN 60601-1 „Medical Electrical
• Never leave the patient unattended at the treatment unit.
Equipment“ and EN 60601-1-2 „Electromagnetic
• The control panel must be clearly visible and accessible Compatibility“ (Medical Electrical Equipment).
for the user.
• ATMOS is not liable for personal injury and damage to
• This product is not re-sterilizable. Repeated reuse of property if
components which are marked with a 2 is forbidden. -- no original ATMOS parts are being used,
In case of repeated reuse these components lose their -- the advice for use in these operating instructions is
function and there is a high infection risk. not being observed,
• In case that there is no adapter attached to the light -- assembly, new settings, alterations, extensions
conductor, touching the light source with either the fingers and repairs have been carried out by personnel not
or any tools should be avoided. On the one hand this authorised by ATMOS.
may damage the lenses and on the other hand there is a • Do not restrict the air supply at the rear of the unit!
risk of injury.
• Prior to starting the treatment application parts have to be
checked regarding their temperature.
• It is not allowed to use flammable substances with the
device.
• The system frame for 2 modules incl. microscope must
be screwed into the floor.
6
2.0 For your safety
Specific safety information ATMOS® Hygrotherm and • For hygienic reasons jet connections must be changed
ATMOS® Variotherm after each patient. This also prevents retrograde
• Metal parts could be hot! contamination of the warm water system.
• Prior to spraying, the water temperature must be checked • Variotherm: May only be used for ear irrigation or
by the user (display)! vestibular stimulation!
• The jet connection must not get into contact with • After the unit is switched on the flow rate must be
contaminated material. checked at least once a day using a volume measuring
funnel. The water jet must not exceed 500 ml/min. The jet
• The jet connection may only be used when a hose tip is
stream must be straight.
installed!
• Prior to use the user must check the outlet pressure it
• Be careful when inserting the hose tip as it could cause
must not exceed 2.2 bar.
damage to the eardrum.
2.2 Hygrotherm / Variotherm: Important advice for maintaining the hygienic status
For loosening cerumen in the auditory meatus and for the stimulation of the labyrinthine system, ATMOS offers the warm water
units Hygrotherm plus (37°C) and Variotherm plus (20° - 47°C).
These units heat the drinking water which comes from the household connection to the preselected temperature. The operating
instructions must be followed, or the increased number of pathogens in the rinse water can affect the health of sensitive
patients.
Requirements for starting up
The water which is provided by the household connection must at least meet the WHO guidelines or the country-specific
guidelines for drinking water.
Connection
Prior to connecting the ATMOS unit fresh water must flow through the wall connection for a period of approx. 1 minute.*
Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70 % alcohol before screwing
them into place.*
Wear disposable gloves when carrying out maintenance work on parts which come into contact with the water.*
* This work is carried out by the ATMOS service technician.
Running operation
Prior to operation switch on the device, remove the irrigation handle from the support for 10 min, so that fresh water is
pumped into the pipes (after long standing periods, e.g. weekend, holidays: 30 min). During this period the heating can be
switched off.
Contact parts e.g. hose tips, must be exchanged after each patient (prevention of retrograde contamination).
Prior to each use, spray water and check the temperature.
Service
Ensure that the suspended particle filter is hygienically changed (see starting up) (dispose of filter and carefully clean the
filter glass). Ensure there is no contact with the contaminated parts.
Depending on the quality of the available drinking water, a biofilm growth cannot be excluded. We, therefore, recommend to
test the drinking water quality at regular intervals (acc. to ISO 6222) at the drinking water connection on the unit and on the
application part. If there is a significant rise in germs between the drinking water connection and the application part then a
biofilm removing process with subsequent disinfection by the ATMOS service must be performed.
7
3.0 Setting up and starting up
>350
ca. 250
<150
160
8
3.0 Setting up and starting up
• The use of demineralised water may affect the function of the waste water disposal!
9
3.0 Setting up and starting up
640
1550
630
730
1961 979,5
2940
10
3.0 Setting up and starting up
Automatic
suction
equipment
Compressed air
Ear irrigation /
thermal
nystagmus
stimulation
Adjustment vacuum
On / Off switch
Display vacuum
1 Hose rinsing
Adjustment
compressed air
Display
compressed air
The plastic adapter of the hose rinsing system ( 1 ) is a consumable (REF 506.2228.1), exchange weekly. It is removed by
twisting it out with a slight rotation.
11
3.0 Setting up and starting up
Insert bacterial filter ( 4 ) Insert splash guard into Insert suction hose ( 7 ) Insert the seal ( 3 ),
into splash guard ( 5 ) lid attach lid to canister (
6)
Connect hose to grommet Insert grommet into lid Insert the canister Fix hose to retainer clip
(1) horizontally into both
connections
340.0057.0
Secretion canister lid 2
530.1108.0
Seal 3
320.0013.0
Bacterial filter 4
340.0054.0
Splash guard 5
12
3.0 Setting up and starting up
Adjust the screws of the feet through the boreholes with a flat-bladed screwdriver scaled
4-5.
Insert phone jack into marked jack Insert application parts into the hanging
strip
First start-up
Prior to shipment each ATMOS® S 61 Servant was checked by the manufacturer for function and safety. In order to ensure the
safe functioning of the device after transport and installation, the following points should be observed:
The user should only operate the device when
1. a functional test was carried out on the device at the place of operation.
2. the operating instructions were read and acknowledged.
After transportation/storage of the device at low temperatures and prior to first start-up it should be kept at room temperature for
at least four hours. If the device is not acclimatised the formation of condensation water is possible and a malfunction might be
the result.
13
4.0 Operation
Display vacuum
Adjustment vacuum
Remove the handle from the support to activate the suction system. The suction system is automatically activated via the
installed light barrier. Set the desired vacuum via the controller. The end of the suction hose must be closed. Only in this case
can vacuum be built up.
at least 30
sec.
After each application rinse the suction hose thoroughly. Add the suction hose (without canula) with the suction nipple to the
suction attachment for the hose rinsing and soak up the rinsing fluid at least 30 sec.
14
4.0 Operation
Attention: Make sure that the water supply system is on and the water supply
secured! Do not use any foaming cleaning agents or disinfectants.
B) Automatically (530.1070.0)
The secretion canister is emptied automatically when the filling level is reached.
Bacterial filter
340.0054.0
Splash guard
Suction hose (only for 312.0827.0
automatic)
006.0008.0, 220mm
15
4.0 Operation
A) Receptal
B) Medi-Vac
16
4.0 Operation
4.3.1 Overview
Front view
1
Irrigation handle
3
1 Handle
4.3.2 Switching on
Attention: Make sure the water supply is guaranteed!
• When the device is switched on, a segment-test is performed. For a short period of time all LEDs will be activated. Visually
check the function of the LEDs during this time.
• Prior to the caloric measurements check the water pressure at the manometer in the service compartment! A target pressure
of 2 bar - max. 2.2 bar must be available. Danger by overpressure!
17
4.0 Operation
Remove the handle hold nozzle in working position and activate trigger perform ear irrigation
18
4.0 Operation
4.4.1 Overview
Front view
1 2 3
9 8 7 6 5
1 Display of stimulation time (double-digit, resolution 1s) 5 Button for selecting the irrigation level (37°C)
2 Adjustment button up or down (for temperature or 6 Button for selecting the warm stimulation level (e.g. 44°C)
seconds setting) 7 Button for selecting the cold stimulation level (e.g. 30°C)
3 Temperature indicator (double-digit resolution 1°C),
8 Button for adjusting the stimulation period
actual value indication
4 Maintenance indicator 9 Button to Start/Stop the stimulation (150 ml/min)
Irrigation handle
3
1 Handle
4.4.2 Switching on
Attention: Make sure the water supply is guaranteed!
• When the device is switched on, a segment-test is performed. For a short period of time all LEDs will be activated. Visually
check the function of the LEDs during this time.
• Prior to the caloric measurements check the water pressure at the manometer in the service compartment! A target pressure
of 2 bar - max. 2.2 bar must be available. Danger by overpressure!
19
4.0 Operation
Remove the handle select temperature and adjust if necessary if required set time press (flashing approx. 10 sec.)
when the Variotherm is ready for use a beep can be heard hold nozzle in working position and activate trigger perform
nystagmus stimulation after the time expires a beep sounds again
20
4.0 Operation
4.4.8 Information about the service display of the ATMOS® S 61 Servant up from software version V 1.2
The ATMOS® S 61 Servant workstation has a service display on the front panel.
The display consists of a red and a yellow LED.
red LED
yellow LED
After switching on the module the electronics goes through a test cycle. The following indications are possible:
If one of the above maintenance cases occurs, please contact your local ATMOS® Service partner.
21
4.0 Operation
Nebulization of medications
(compressed air)
• Make sure equipment and hoses are firmly connected in order to build up a sufficient pressure.
• If you use politzer olives, control pressure in acc. with the appliance.
4.6.1 Activation
Remove the handle from the support to activate the compressed-air system. The compressed-air system is automatically
activated via the installed light barrier.
22
4.0 Operation
Adapt: Deposit:
Insert () the handle onto the 1 Insert the medication bottle
medication bottle. top down in the support.
Engage, then lift medication 2 Press activator () and pull
1 bottle with the handle from handle () backwards.
the support ().
By pulling the trigger,
compressed-air will be
applied into the sprayer ().
3
2
2 To start the ear irrigation, close the vent valve () and
press the adjusting lever (). To terminate ear irrigation,
release the adjusting lever () and the vent valve (). Ear
irrigation stops immediately!
! Prior to every use the glass bottles must be checked for
intactness (cracks, chippings on the winding, etc.). Broken
1 glass vials may not be used for ear irrigation.
Adjusting lever
Vent valve
LED port (for light source or headlight), optional connection for nystagmus
binoculars
23
4.0 Operation
Press A.
The mirror quick-heater heats up for 10 seconds and then switches off automatically.
! Risk of burns!
Prior to each use on your patient check the mirror temperature (e.g. on the back of your hand).
Clean and disinfect the storage quivers regularly! For details please observe the instructions in chapter “5.0 Cleaning and care”.
24
4.0 Operation
25
5.0 Cleaning and care
if
required
)) The described measures relating to cleaning and )) Always observe the concentration specifications and
disinfection resp. sterilisation do not replace the relevant instructions by the respective manufacturer!
instructions which must be adhered to prior to operation! • Do not use
• For disinfection, you may use all surface and instrument -- Disinfectants which contain organic or inorganic acids
disinfectants listed in the following sub-chapter or bases as they could cause corrosion damage.
“Recommended disinfectants”. -- Disinfectants containing chloramides or phenol
• Please ensure that all surfaces are dry wiped. Use a derivatives, since these may cause stress cracks in
disposable cloth to absorb any liquid. the plastic material used.
• If any disinfectant is spilled, make sure to dry wipe the
surface immediately in order to prevent the liquid from
penetrating gaps and edges.
• The surfaces of the ATMOS® S 61 Servant ENT • All application parts which are exposed to direct contact
workstation are resistant against all surface disinfectants with the patient during treatment must be exchanged
listed in chapter „Recommended disinfectants“. or cleaned and disinfected immediately for hygienic
• Wipe the unit surface with a cloth moistened with a reasons.
cleaning or disinfecting solution. • Only deposit clean instruments on the board!
• Disinfectant sprays or disinfectant tissues may also be • Clean and disinfect the instruments regularly!
used for cleaning and disinfection.
ªª Please observe that the alcohol contained in these
agents could corrode or cloud the protective covers if
employed on a long term basis.
26
5.0 Cleaning and care
27
5.0 Cleaning and care
28
5.0 Cleaning and care
Other surfaces
Disinfectant Ingredients in 100 g Manufacturer
Dismozon® pur magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie,
(Granulate) Hamburg
End of product 12/2014
Dismozon® plus magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie,
(Granulate) Hamburg
Kohrsolin® FF glutaral 5 g Bode Chemie,
(Application concentrate) benzyl-C12-18-alkyldimethyl-ammonium chlorides 3 g Hamburg
didecyldimethylammonium chloride 3g
Perform® Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr,
Norderstedt
Terralin® Protect benzyl-C12-16 alkyldimethyl-, chloride 22 g Schülke & Mayr,
(Application concentrate) 2-phenoxyethanol 17 g Norderstedt
aminoalkylglycine 0.9 g
non-ionic surfactants, perfumes
Surface disinfection F 312 alkyl-benzyl-dimethyl-ammonium chloride 13 g Dürr Dental, Bi-
non-ionic surfactants, complexing agents, hexyl cinnamal, butyl phenyl methyl etigheim-Bissingen
proionale, linalool
When disinfectants containing aldehyde and amine are used on the same object colour changes may occur.
29
5.0 Cleaning and care
30
6.0 Hygiene Plan Cleaning and disinfection plan
ATMOS® S 61 Servant
What How When Who
Qualified and trained
application
After each
staff who are familiar
Monthly
Weekly
(Please fill in the
Parts to be reprocessed Cleaning Disinfection Sterilization responsible person
Daily
-> use a water-based
overhead marker)
Secretion canister
Hose connection (grommet) X X2,4,5 Cleaning and disinfection (manual or automatic) X
Seal X X 2,4,5
Cleaning and disinfection (manual or automatic) X
Suction hose in the canister X X2,4,5 Cleaning and disinfection (manual or automatic) X
Empty when the canister is full; at least daily;
Secretion canister X X X
Cleaning and disinfection (manual or automatic)
Disposable canister system Exchange and disposal of full canister X
Rinsing lid with rinsing hose X X2,4,5 Cleaning and disinfection (manual or automatic) X
Cleaning and disinfection (manual or automatic); cleaning
Rinsing bottle X X2,4,5.6 X
in the dishwasher with the glass care programme
Sprayer head X2,4,5 Multiple rinsing of the sprayer head with water X
Weekly exchange of the hose or when changing the
Hose at sprayer head X X X
medication
Cleaning in a cleaning and disinfection device; weekly or
Sprayer bottle X X2,4,5.6 X
when changing the medication
Exchange after each application, cleaning and
Politzer olive X X 2,4,5.6
X
disinfection
Exchange after each application, cleaning and
Politzer connection X X2,4,5.6 X
disinfection
Endoscope management
Plastic quiver X X2,4,5 Cleaning with a brush; disinfection X
31
6.0 Hygiene Plan
application
staff who are familiar
Notices
After each
C D S with reprocessing.
Monthly
Weekly
(Please fill in the re-
Parts to be reprocessed Cleaning Disinfection Sterilization sponsible person, use
Daily
a water-based over-
head marker)
Instrument management
Immerse instruments into solution immediately after use,
complete wetting is required, air must be removed from
any cavities, after the contact time instruments must
ENT instruments X X2,4,5 X X
be rinsed with water, have to be dried and sterilised
afterwards. Please also observe the ATMOS operating
instructions for ENT instruments.
Instrument bowl X X4 Cleaning and disinfection (manual) X
Visualization
ATMOS® Cam 21 / 31 X X3 Wipe cleaning and disinfection X
Radiofrequency surgery
ATMOS® RS 221 (surface) X X3 Wipe cleaning and disinfection X
Surfaces
Housing X X3 Wipe cleaning and disinfection X
Recommended disinfectants 4)
Manual disinfection of instruments: 7)
Endoscopes - manual disinfection: The above stated hygiene requirements are based on the regulations
according to the Medical Devices Act, the Medical Devices Operator
• Korsolex® med AF (Bode Chemie) Helipur® H plus N (BBraun) Ordinance, §18 IfSG and the recommendations of the Robert Koch Institute.
3)
Surface disinfection for coated surfaces: • Korsolex® basic (Bode Chemie) Helix® Ultra (BBraun) Definition of the required reprocessing steps result from the
• Green & Clean SK (ATMOS) • Korsolex® plus (Bode Chemie) Korsolex® Basic (Bode Chemie) recommendations of the Robert Koch Institute: „Requirements for the
• Dismozon® plus (Bode Chemie) • Korsolex® extra (Bode Chemie) neodisher® MediClean forte (Dr. Weigert) reprocessing of medical products“, from Robert Koch Institute. The medical
• Kohrsolin® FF (Bode Chemie) • neodisher® Septo MED (Dr. Weigert) Sekusept® aktiv (Ecolab) products were categorised in the risk groups uncritical, semi-critical
and critical. The reprocessing measures mentioned in this cleaning and
• Perform® (Schülke & Mayr) • neodisher® Septo 3000 (Dr. Weigert) disinfection plan are a recommendation of ATMOS MedizinTechnik. Any
• Terralin® Protect (Schülke & Mayr) • Sekusept® PLUS (Ecolab)
8)
Endoscopes - automatic disinfection: additional reprocessing measures are at the operator‘s discretion.
• Sekusept® aktiv (Ecolab) Korsolex® Basic (Bode Chemie) All the recommended disinfectants which are stated herein are listed
Other surfaces: neodisher® MediClean forte (Dr. Weigert) disinfectants (VAH/RKI) and have been tested on their suitability of use on
• Dismozon® plus (Bode Chemie) • Gigasept® Instru AF (Schülke & Mayr)
• Gigazyme® (Schülke & Mayr) Gigasept® FF neu (Schülke & Mayr) the ATMOS® S 61 Servant. ATMOS MedizinTechnik cannot be hold liable for
• Kohrsolin® FF (Bode Chemie) Endozime® AW Plus (Ruhof) any damage caused by wrong concentration of the disinfectants or by the
• Mikrobac® forte (Bode Chemie) • Gigasept FF neu (Schülke & Mayr) application of any other disinfectants.
ADAPTACLEAN™ (ASP) Patients with suspicion of a clinical disease or who developed a
• Perform® (Schülke & Mayr) 5)
Automatic disinfection of instruments: transmissible spongiform encephalopathy (CJK, vCJK, etc.) have to be
• Terralin® Protect (Schülke & Mayr) • Dismoclean® 24 Vario (Bode Chemie) treated at facilities which are able to provide for the necessary preventive
For concentrations, contact time, temperature,
• Surface disinfectant FD 312 (Dürr Dental) • Dismoclean® 28 alka med (Bode Chemie) measures against infection. The reprocessing of the reusable instruments
material compatibility, please see the relevant and material may only be performed at facilities which have an externally
• Dismoclean® twin basic/twin zyme (Bode Chemie) information from the manufacturer. certified QM Management acc. to DIN EN ISO 13485.
• neodisher® FA (Dr. Weigert) The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250
• neodisher® MediClean forte (Dr. Weigert) always have to be considered.
• Thermosept® alka clean forte (Schülke & Mayr)
Important information • Thermosept® RKN-zym (Schülke & Mayr) ATMOS MedizinTechnik GmbH & Co. KG
Wrong concentration of disinfectants Ludwig-Kegel-Str. 16 79853 Lenzkirch/Germany
Wipe cleaning and disinfection:
may lead to material damage! Phone +49 7653 689-0 Fax +49 7653 689-190
All surfaces have to be wiped with a clean 1)
Please observe the manufacturer‘s operating
(disposable) wipe which is damped with instructions. info@atmosmed.de www.atmosmed.de
disinfectant solution. The entire surface has 2)
Preferred: machine cleaning and disinfection in the
to be wiped thoroughly and may not be dried washer disinfector GA3GB.110100.0 2017-12 Index: 14
afterwards. 6)
Material dimensionally stable at 134°C
32
7.0 Maintenance and Service
• The ATMOS® S 61 Servant ENT workstation is equipped with maintenance-free pumps for suction and compressed air.
Nevertheless, to ensure correct functioning of the unit over a long period of time simple maintenance work which can either
be done by the user himself, or, if desired, by service technicians, is necessary from time to time:
-- To ensure correct functioning of the automatic irrigation and suction mechanism, switch off the ENT unit prior to changing
the secretion canister!
-- There is a service compartment (lower part of the function column) which contains the parts needed for the maintenance
procedures. The possible maintenance procedures are described in the following chapters.
• 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 specifications.
-- With integrated Variotherm: Carry out an inspection according to the manufacturer‘s specifications every 12 months.
33
7.0 Maintenance and Service
34
8.0 Troubleshooting
Suction
Low or no suction rate, but vacuum Suction hose is clogged Clean suction hose
gauge indicates vacuum Active oversuction protection Check oversuction protection
Filter moistened/blocked Replace filter
Low or no suction rate, but vacuum System leaky Check all joints, new assembly of the system
gauge indicates few or no vacuum Suction hose snapped off Remove breaks, pass hose a different way
Vacuum controller is open Set regulator to higher/maximum vacuum
Secretion penetrated the suction Inform the service department
pump
Suction pump does not switch on or Draggled/defect light barrier in Clean both light barriers openings in the
off suction hose holder suction hose holder, if necessary inform service
department
No suction, but force pump is Positions of handles have been Insert handles in the right holder
operating mixed up
Compressed air
Compressed air pump does not Draggled/defect light barrier in Clean both light barriers openings in the
switch on or off compressed air holder compressed air holder, if necessary inform
service department
No compressed air, but suction Positions of handles have been Insert handles in the right holder
pump is operating mixed up
No adequate pressure build-up Leaky connections Check joints, if necessary inform service
department
Sprayer does not work Sprayer is clogged Clean sprayer, clean ventilation borehole in
sprayer head
35
8.0 Troubleshooting
Heating system
No heating Temperature sensor, control or Inform the service department
heating element defective
Hygrotherm / Variotherm
Error in temperature display
„E1“ No water (water pressure <0.5 bar) • Check, whether the water supply delivers a
pressure of at least 2 bar (is the water-tap
open?).
• Filter clogged?
„E2“ -5 V is missing (supply voltage on • Inform the service staff.
the control board)
„E3“ Break of the safety NTC • Inform the service staff.
„E4“ Short-circuit of the safety NTC • Inform the service staff.
„E5“ Break of the regulating NTC • Inform the service staff.
„E7“ Temperature too high, display only • Check, whether temperature setting is too
in the stimulation or irrigation mode. high. If necessary adjust the set temperature
to a lower value.
• Inform the service staff.
„E8“ Short-circuit of the regulating NTC • The temperature probe from the regulating
NTC must be checked by a service
technician.
36
9.0 Consumables, Accessories, Spare Parts
9.1 Consumables
Consumables for disposable secretion management REF
Receptal® 1.0 l bag, not autoclavable 312.0463.0
9.2 Accessories
Accessories for ear irrigation / thermal nystagmus stimulation REF
Ear irrigation bowl 505.0353.0
Ear irrigation bowl with separate suction channel 530.2070.0
for the independent use of the ear irrigation bowl. Clipboard (REF 530.0010.0) is required
Jet connection for water irrigation handle 80 mm 508.0427.0
Jet connection for water irrigation handle 110 mm 508.0429.0
Hose tips, 30 pcs. 502.0844.0
flexible hose tips, to be slipped on jet connection for exact guiding of the water jet
Splash protection to be slipped on jet connection 501.0331.0
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9.0 Consumables, Accessories, Spare Parts
38
10.0 Technical data at complete equipment
Please note the technical specifications of the single devices in the separate operating instructions!
39
10.0 Technical data at complete equipment
11.0 Disposal
40
12.0 Notes on EMC
• 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 influence 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.
The ATMOS® S 61 Servant ENT workstation is intended for use in the electromagnetic environment specified below. The
customer or user of the ATMOS® S 61 Servant ENT workstation should ensure that it is used in such an environment.
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge ± 6 kV Contact ± 6 kV Contact Floors should be wood, concrete, or ceramic
(ESD) according to IEC ± 8 kV Air ± 8 kV Air tile. If floors are synthetic, the relative
61000-4-2 humidity should be at least 30 %.
Fast electrical transient/ ± 2 kV Mains ± 2 kV Mains Mains power quality should be that of a
burst IEC 61000-4-4 ± 1 kV I/Os typical commercial or hospital environment.
Surges IEC 61000-4-5 1 kV 1 kV Mains power quality should be that of a
Common Common typical commercial or hospital environment.
2 kV 2 kV
Differential Differential
Magnetic field at power 3 A/m Inapplicable Power frequency magnetic fields should
frequency 50/60 Hz acc. be that of a typical commercial or hospital
to IEC 61000-4-8 environment.
41
12.0 Notes on EMC
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Voltage Dips / Dropout < 5 % UT < 5 % UT Mains power quality should be that of a
IEC 61000-4-11 (> 95 % Dip of the UT) (> 95 % Dip of the UT) typical commercial or hospital environment.
If the user of the ATMOS® S 61 Servant
for 0.5 Cycle for 0.5 Cycle
ENT workstation requires continued function
during interruptions of the energy supply,
40 % UT 40 % UT it is recommended to supply the ATMOS®
(60% Dip of the UT) (60% Dip of the UT) S 61 Servant ENT workstation from an
uninterruptible power supply or a battery.
For 5 cycles For 5 cycles
70% UT 70% UT
(30 % Dip of the UT) (30 % Dip of the UT)
For 25 cycles For 25 cycles
< 5 % UT < 5 % UT
(>95 % Dip of the UT) (>95 % Dip of the UT)
for 5 s for 5 s
NOTE UT is the mains alternating current prior to application of the test levels.
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12.0 Notes on EMC
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
reflection of buildings, objects and people.
a
The field 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 field strength at
the location where the ATMOS® S 61 Servant ENT workstation is used exceeds the above compliance level, the ATMOS® S
61 Servant ENT workstation 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 ATMOS® S 61 Servant ENT
workstation.
b
Within the frequency range of 150 kHz to 80 MHz the field strength should be below 3 V/m.
NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by
absorption and reflection of buildings, objects and people.
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ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
atmos@atmosmed.de
www.atmosmed.com