English
ATMOS® Chair M 2
Operating Instructions
GA1GB.130205.0
2018-08 Index: 06
Table of contents
1.0 Introduction ..................................................... 3-5
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................3
1.3 Function ................................................................3
1.4 Explanation of pictures and symbols ....................4
1.5 Scope of supply ................................................... 5
1.6 Transport and storage ...........................................5
2.0 For your safety ....................................................6
3.0 Setting up and starting up ............................. 7-8
3.1 Setting up ..............................................................7
3.2 Starting up.............................................................7
3.2.1 Operating elements...............................................7
3.3 Electrical connection .............................................8
4.0 Operation ....................................................... 9-12
4.1 Positioning the patient...........................................9
4.2 Adjusting the seat height.......................................9
4.3 Rotating the upper part .........................................9
4.4 Adjusting the backrest...........................................9
4.5 Adjusting the headrest ........................................10
4.6 Removing the foot support ..................................10
5.0 Cleaning .........................................................11-12
5.1 General information on cleaning and disinfection 11
5.2 Cleaning and disinfection of the device surface
and upholstery ....................................................11
5.3 Recommended surface disinfectants ..................12
5.4 Recommended upholstery disinfectants .............12
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
6.0 Maintenance and Service .................................13
6.1 Replacing the fuse ..............................................13
6.2 Sending in the device..........................................13
7.0 Troubleshooting ................................................13
8.0 Accessories and spare parts ...........................14
8.1 Accessories .........................................................14
8.2 Spare parts .........................................................14
9.0 Technical data ...................................................15
10.0 Disposal .............................................................16
11.0 Notes on EMC .............................................. 17-19
2
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® Chair M 2 safely,
correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and downtimes. 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
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
®
• The product ATMOS
medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.
• The product ATMOS
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.
Chair M 2 bears CE marking according to the EC Directive of the council for
®
Chair M 2 complies with all applicable requirements of the Directive 2011/65/EC
®
Chair M 2 and are therefore a must besides regular cleaning.
®
Chair M 2 will be preserved.
1.2 Intended use
Name: ATMOS® Chair M 2
Main function: This patient‘s chair enables the optimum
positioning of the patient with regard to height and access
(sitting or horizontal).
Medical indications / application: Positioning of the patient
during standard ENT examinations and / or therapy.
Specication of the main function:
• Electrical height adjustment via foot switch from 56.5 cm
up to 76.5 cm
• Upper part of the chair 360° rotatable
• Innitely variable height adjustment of the backrest from
vertical up to the horizontal position
• Integrated height adjustable headrest
• Foot support
Application organ: Positioning of the patient
Application time: Temporarily (max. of 60 minutes)
Application site: In clinics and practices for ENT doctors and
phoniatricians. The application of the patient’s chair must be
executed by medically trained persons only.
Contraindications: None
The product is: active
Sterility: Not sterile
Single-use product / reprocessing: No single use product
1.3 Function
®
The ATMOS
adjustment. The height can be adjusted between 56,5 and
76,5 cm and is controlled by an integrated foot switch. The
upper part of the chair rotates 360° and can be locked at any
desired position by a hand lever operated locking mechanism.
The shoulder-high, reclining backrest moves from +7° forward
to fully horizontal.
Chair M 2 is equipped with an electrically height
3
1.0 Introduction
1.4 Explanation of pictures and symbols
Short cuts / symbols contained in these operating instructions
Follow the arrows
Please press where
dot indicates
Please read,
important information
Graphic symbols contained in these operating instructions
Warning, special diligent notice
General information
■
Numeration
●
Subnumeration
→
Check
!
®
Symbols of ATMOS
Chair M 2
) Important information
click
Move, plug... in this
direction
Turn, shift ... in this
direction
Replace
Replace
Engage, check cor-
rect t
REF
Degree of protection type B
Order number
This product complies with the
relevant requirements of EU Directive
4
1.0 Introduction
1.5 Scope of supply
• Prior to dispatch, the ATMOS® Chair M 2 was subjected to an extensive functional test and was carefully packed.
Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
Basic device
Operating
Instructions
Power cable
1.6 Transport and storage
• After the transport of the device in temperatures below
0°C or prior to rst start up it should be kept at room
temperature for at least six hours. If the device is not
acclimatized it may not be used as damages to the
electronic components may be the result.
• Only transport the device in a shipping carton, which is
padded and offers sufcient protection.
• If damage occurs during transport:
- Document and report the transport damage.
- Send the device to ATMOS (Chapter „6.2 Sending
in the device“ on page 13).
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
5
2.0 For your safety
!
For your safety
D
• The ATMOS® Chair M 2 has been designed in accordance
with IEC 60601-1/EN 60601. The equipment conforms
to VDE Safety Class I and must only be connected to a
properly installed earthed socket.
• The Chair may be used only under supervision (IEC
60601-1 / EN 60601-1).
• Prior to starting the chair for the rst time, check whether
the supply voltage indicated on the line voltage selector
corresponds to the value of your local mains supply.
• For mains supply, only use the power cable supplied (or an
equivalent one).
• Check proper assignment when assembling country-
specic connections:
- green / yellow: protective conductor
- blue: neutral conductor
- black or brown: phase
• Prior to rst starting up, all connecting leads must be
checked on damage. Defect cables must be replaced.
• To disconnect the chair from the mains supply, rst
remove the plug from the safety connection socket. Then
disconnect the connection line from the chair. Never touch
plug or line with wet hands.
• Please observe the ambient conditions stated in the
technical data (chapter 8.0).
®
• The ATMOS
explosion-hazardous areas. Explosion-hazardous areas
may be caused by the use of ammable anaesthetics, skin
cleansing products and skin disinfectants.
• Ensure that your patient sits in the middle of the seat.
A constant unilateral strain on the seat can damage the
surface.
• The user must be familiar with the operation of the chair.
• 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.
• 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.
• The electric motor is protected by an integrated thermo
protection switch. After 1.5 minutes of continued operation,
the motor needs a cool down period of approx. 8.5
minutes. If the thermo protection switch activates, the
motor needs a cool down period of approx. 20 minutes.
Chair M 2 is not designed for use in
6
3.0 Setting up and starting up
3.1 Assembly
• Always place the device on level, solid surface.
3.2 Starting up
• Set up product at the desired spot. Any oor unevenness
must be compensated for.
• Check that the upper part of the chair can rotate freely.
• Peruse safety information in part 2.0 prior to starting up
the device for the rst time.
• Finally, connect power cable.
3.2.1 Operating elements
Fig. 1.
Headrest
Operating lever for backrest
Operating lever for arresting brake
Foot support (optional)
Foot switch for adjusting the seat height
7
3.0 Setting up and starting up
3.3 Electrical connection
The ATMOS® Chair M 2 is supplied with a power cable and
IEC connection. Insert the power cord to the IEC socket at
the back side of the chair base and the wall mounted power
outlet.
Make sure, power outlet features a proper ground connection.
Find all relevant electrical data (voltage and nominal
frequency) as well as the data for fuses on the label located
between the sockets.
To disconnect the device, pull the mains plug out of outlet
socket.
) There is no indication that the product is hooked up to line
power.
) Disconnect chair, if not in use, during service and repair
work and or for cleaning.
8
4.0 Operation
Fig. 2. Foot switch
4.1 Positioning the patient
Ensure that your patient sits in the middle of the seat.
A constant unilateral strain on the seat can damage the
surface.
4.2 Adjusting the seat height
The height adjustment of seat cushion level is controlled by 2
foot switches (g.2):
= Up
= Down
®
Furthermore, the ATMOS
Down (homing)” function, to lower the upper part of the chair
down to its lowest level after a short tap on the foot switch.
Pressing the right foot switch for less than 0.5 seconds will
move the chair to home position. To stop the movement, just
briey tap the switch again.
Chair M 2 features an “Auto –
Fig. 3.
Lever element for the backrest
Operating lever for arresting brake
4.3 Rotating the upper part
The upper part of the chair with the patient can be completely
rotated after having loosened the brake with the locking lever
, g. 3).
(
The upper part with the patient can then be rotated in the
desired direction.
If the brake is only slightly xed the chair can be rotated
without loosening the brake.
4.4 Adjusting the backrest
• Press lever element (, g. 3) downwards.
• Adjust backrest to the desired position.
• Release lever element which will then return to its initial
position,
• Backrest is arrested.
9
4.0 Operation
4.5 Adjusting the headrest
• Loosen the arresting button on the rear of the backrest by
turning it anti-clockwise,
• Adjust the headrest to the desired height (it may not be
extended by more than 10 cm),
• Arrest the headrest by turning the arresting button
clockwise.
4.6 Removing the headrest
• After having loosened the arresting button, the headrest
can be removed upwards from its support.
4.7 Removing the foot support
• Loosen the arresting screws (bottom of the seat).
• Remove the foot support forward.
10
5.0 Cleaning and care
5.1 General information on cleaning and disinfection
Prior to cleaning
Medical chairs like the ATMOS® Chair M 2 must be fail safe at all times.
We therefore recommend:
prior to each use:
if
necessary
) 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 upholstery
disinfectants listed in chapter 5.3 and 5.4 “Recommended
disinfectants”.
) 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, phenol derivatives
or anionic tensides, as these may cause stress cracks
in the material used for the housing of the unit.
5.2 Cleaning the device surface and upholstery
If liquid has penetrated the device, it may not be operated again until it has been checked by the authorised customer service
centre.
®
• The surfaces of the ATMOS
5.3 and 5.4. Nevertheless after any length of time discolourations could possibly develop. Polar solvents (e.g. acetone or
chlorinated hydrocarbons (CCs)) may not be used for cleaning and disinfecting.
!
• Disconnect the power plug from the power supply prior to cleaning and disinfecting the device surface.
• The device itself can be wiped off with a moist (not wet) cloth.
Chair M 2 are resistant against all the recommended surface disinfectants stated in chapter
Do not use aggressive or abrasive cleansing agents. For the upholstery usual dry foam may be used.
Treatment with a commonly used care product for articial leather is recommended once a week in order to keep the upholstery
soft and smooth.
11
5.0 Cleaning and care
5.3 Recommended surface disinfectants
• The surfaces of the ATMOS® Chair M 2 can be cleaned / wiped with disinfectants containing the following active ingredients:
- QAV (quarternary ammonium compounds)
• Substances such as blood need to be removed immediately to prevent stains.
5.4 Recommended disinfectants for the upholstery
Disinfectant Ingredients (in 100 g) Manufacturer
ATMOS Green & Clean SK
(Application solution)
Alkyl dimethyl benzyl ammonium chloride
Dialkyl dimehtyl ammonium chloride
Alkyl dimethyl ethyl benzyl ammonium chloride
< 1 g
Metasys, Rum (Austria)
< 1 g
< 1 g
12
6.0 Maintenance and Service
The ATMOS® Chair M 2 is maintenance-free except for
a possible fuse replacement (see section 6.1). In case of
malfunctions, please contact your local authorized ATMOS
service technician.
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.
At least every 24 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.
6.1 Replacing the fuse
) Before replacing the fuse, unplug the mains plug.
• To open the fuse socket rotate top counter clockwise,
• Exchange fuse,
• To close fuse socket, rotate top clockwise.
6.2 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.
7.0 Troubleshooting
Error indication Possible cause Remedy
Device does not start • Power plug is tted badly • Check connection at wall socket
• No mains voltage • Check main fuse
• Check mains plug on perfect t at the device
• Defect fuse • Exchange of fuse
In case of malfunctions, please contact your local authorized ATMOS service technician.
13
8.0 Accessories and spare parts
REF
8.1 Accessories
Child seat on request
8.2 Spare parts
14
9.0 Technical data
Voltage 230 V~ ± 10 %; 50 Hz
Special voltage 120 V~ ± 10 %; 60 Hz
Current consumption Max. 2.5 A
Power consumption Max. 520 VA
Fuses T 3.15 A / 250 V
Operating time 1.5 min operation, 8.5 min rest period
Dimensions H x W x D 127.5 x 63.0 x 84.0 cm
Weight 82 kg
Backrest height 80 cm
Backrest inclination +7° up to -90 ° (horizontal position)
Dimensions seating surface L x W 54.0 x 48.0 mm
Seat height 56.5 cm to 76.5 cm
Vertical lift 20 cm
Vertical speed 13 mm/sec.
Rotation 360° without detent
Load 150 kg
Protective earth conductor resistance
Earth leakage current
Enclosure leakage current
Patient leakage current
Ambient conditions transport / storage
• Temperature -10...+50 °C
• Humidity without condensation 30...95 %
• Air pressure 500...1060 hPa
Ambient conditions for operation
• Temperature +10...+35 °C
• Humidity without condensation 30...95 %
• Air pressure 700...1060 hPa
Period tests Repeat test of the electrical safety every 24 months.
Safety class (EN 60601-1) I
Degree of protection Application parts type B
Protection class IP 20
Classication according to Appendix IX EC
Directive 93/42/EEC
CE marking CE
GMDN code 16437
UMDNS code 16-437
ID No. (REF) 537.0000.0
Max. 0.1 Ω
Max. 0.5 mA
Max. 0.1 mA
Max. 0.1 mA
Recommended: inspection according to the manufacturer‘s
specications.
Class 1
537.0000.4
Issue of technical data: 16.07.2018
15
10.0 Disposal
• The ATMOS® Chair M 2 does not contain any hazardous substances.
• The housing is recyclable.
• Device and accessories must be decontaminated prior to disposal.
• Pay attention to a careful separation of the different materials.
• Please observe national disposal regulations (e.g. waste incineration).
Disposal within the EC
The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of
professionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please
observe existing national laws and rules for disposal of old devices in the respective country.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) regulates the disposal of electrical devices. In order
to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it
directly to ATMOS MedizinTechnik for a professional disposal.
Before disposal respectively before transport all parts, which came into contact with the patient must be thoroughly
cleaned, disinfected. The device surface must be disinfected.
16
11.0 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 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.
11.1 Guidelines and Manufacturer´s Declaration - Emissions
The ATMOS® Chair M 2 is designed for operation in the environment specied below. The customer or user of the ATMOS®
Chair M 2 should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
®
Harmonic emissions according to
IEC 61000-3-2
Voltage uctuations/icker according
to IEC 61000-3-3
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.
Class A The ATMOS
establishments, including domestic and those connected
Corresponds
directly to a public power supply network that supplies
buildings used for residential purposes.
Chair M 2 is suitable for use in all
11.2 Guidelines and Manufacturer's Declaration - Immunity
The ATMOS® Chair M 2 is designed for operation in the electromagnetic environment specied below. The customer or user of
the ATMOS
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge
(ESD) according to IEC
61000-4-2
Fast electrical transient/
burst IEC 61000-4-4
Surges IEC 61000-4-5 ± 1 kV common-mode
Magnetic eld at power
frequency 50/60 Hz acc.
to IEC 61000-4-8
®
Chair M 2 should ensure that it is used in such an environment.
± 6 kV Contact
± 8 kV Air
± 2 kV Mains
± 1 kV I/Os
± 2 kV differential mode
3 A/m Inapplicable Power frequency magnetic elds should
± 6 kV Contact
± 8 kV Air
± 2 kV Mains
± 1 kV I/Os
± 1 kV common-mode
± 2 kV differential mode
Floors should be made of wood or concrete
or tiled with ceramic tiles. If oors are
synthetic, the relative humidity should be at
least 30 %.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
be that of a typical commercial or hospital
environment.
17
11.0 Notes on EMC
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 Cycle)
40 % UT
(60% Dip of the UT
for 5 cycles)
< 5 % UT
(> 95 % Dip of the UT
for 0.5 Cycle)
40 % UT
(60% Dip of the UT
for 5 cycles)
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the ATMOS
®
Chair M 2 requires
continued operation upon the occurrence
of disruptions in the energy supply, the
ATMOS
®
Chair M 2 should make use of an
uninterruptible power supply or a battery.
70 % UT
(30% Dip of the UT
for 25 cycles)
< 5 % UT
(> 95 % Dip of the UT
for 5 s)
70 % UT
(30% Dip of the UT
for 25 cycles)
< 5 % UT
(> 95 % Dip of the UT
for 5 s)
NOTE UT is the alternating mains voltage prior to application of the test levels.
11.3 Guidelines and Manufacturer's Declaration - Immunity
The ATMOS® Chair M 2 is designed for operation in the electromagnetic environment specied below. The customer or user of
the ATMOS
Immunity Test
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
®
Chair M 2 should ensure that it is used in such an environment.
IEC 60601- Test
Level
3 Veff
150 kHz to 80 MHz
3 V/m
Compliance Level Electromagnetic Environment - Guidance
3 V
10 V/m
80 MHz to 2.5 GHz
Portable and mobile radio equipment should be used
no closer to the ATMOS
®
Chair M 2, including cables,
than the recommended distance calculated according
to that which applies to the transmission frequency.
Recommended distances:
d = 3.5/3 √ P
d = 3.5/10√ P
d = 7/10 √ P
18
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:
11.0 Notes on EMC
NOTE 1
With 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 eld strength measured at
the site where the ATMOS
to demonstrate proper function. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the ATMOS
b
Within the frequency range of 150 kHz to 80 MHz the eld strength should be below 3 V/m.
11.4 Recommended separations between portable and mobile RF Communications
equipment and the ATMOS® Chair M 2
The ATMOS
customer or user of the ATMOS
distance between portable and mobile HF communication equipment (transmitters) and the ATMOS
the output of the communication device as indicated below.
®
Chair M 2 is intended for use in an electromagnetic environment in which HF disturbances are controlled. The
®
Chair M 2 is used exceeds the compliance level above, the ATMOS® Chair M 2 must be observed
®
Chair M 2.
®
Chair M 2 can thereby help to prevent electromagnetic interference by maintaining a minimum
®
Chair M 2 - depending on
Safety distance, depending on transmit-frequency m
Nominal capacity
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
of the transmitter
W
d = 3.5/3 √ P
d =3,5/10 √ P
d = 7/10 √ P
0.01 0.12 0.035 0.07
0.1 0.37 0.11 0.22
1 1.17 0.35 0.7
10 3.7 1.1 2.2
100 11.7 3.5 7
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
With 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.
19
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
atmos@atmosmed.de
www.atmosmed.com
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