Atmos Chair 41 Gyne Operating Instructions Manual

Page 1
English
MedizinTechnik
ATMOS Chair 41 Gyne
Operating instructions
503.0550.B 2019-07 Index: 20
Page 2
Table of contents
1.0 Introduction ............................................................... 5-7
1.1 Intended use .................................................................. 5
1.2 For your safety ............................................................... 5
1.3 Main characteristics ....................................................... 6
1.4 Type label ....................................................................... 7
1.5 Technical information ..................................................... 7
2.0 Scope of supply ........................................................... 8
3.0 Setting up and starting up ...................................... 9-10
4.0 Operation ............................................................... 11-12
4.1 Controls .........................................................................11
4.2 Programming ................................................................ 12
4.3 Leg rest adjustment ..................................................... 12
4.3 Leg rest (REF 503.0552.0) .......................................... 12
5.0 Cleaning and care ................................................. 13-14
5.1 Cleaning ....................................................................... 13
5.2 Paper roll replacement .......................................... 13 - 14
5.3 Recommended surface disinfectants ........................... 14
5.3.1 Recommended disinfectant for cushion ....................... 14
6.0 Maintenance and servicing ....................................... 15
6.1 Exchange of upholstery ................................................ 15
7.0 Trouble shooting ........................................................ 16
ATMOS
MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch Deutschland/Germany
8.0 Accessories, further options, consumables .... 17 - 18
8.1 Accessories ............................................................. 17-18
8.2 Further options ........................................................ 17-18
8.3 Consumables ............................................................... 18
9.0 Technicalspecications ............................................ 19
10.0 Disposal ...................................................................... 20
11.0 Notes on EMC ........................................................ 21-23
Phone: + 49 7653 689-0
e-mail: atmos@atmosmed.de Internet: http://www.atmosmed.de
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General survey
This survey also shows options*, which are not part of the basic equipment!
MAGNETKISSEN
*
MAGNETIC PILLOW COUSSIN MAGNÉTIQUE
* GRIFF
HANDLE POIGNEÉ
BEINHALTER
*
LEG SUPPORT ECARTEUR
RÜCKENLEHNE BACKREST DOSSIER
KOLPOSKOPHALTER
*
COLPOSCOPE ARM BRAS POUR COLPOSCOPE
SITZFLÄCHE SEAT SIÉGE
SEKRETSCHALE
*
BASIN CUVETTE
*
FUßSTÜTZE FOOTREST APPUI-PIED
BODENPLATTE BASE BASE
FUßSTEUERUNG FOOT CONTROL PÉDALE
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1.0 Introduction
These operating instructions contain important notes on how to operate the ATMOS Chair 41 Gyne
safely, correctly and e󰀨ectively. Their reading helps to avoid risks, and also to reduce repair costs
and down-time. That 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. Full or partial reproduction is subject to prior written approval from ATMOS.
These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS Chair 41 Gyne and are therefore a must besides regular cleaning.
Repair work and safety inspections 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 Chair 41 Gyne will be preserved.
●The product ATMOS Chair 41 Gyne bears CE marking CE according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this directive.
●The product ATMOS Chair 41 Gyne complies with all applicable requirements of the Directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”).
●The declaration of conformity and our general standard terms and conditions can be obtained on our website at www.atmosmed.com.
●The quality management system applied at ATMOS has been certied according to international standards EN ISO 9001 and EN ISO 13485.
●Prior to start-up please peruse chapter 1.2 „For your safety“, in order to be prepared for any possible dangerous situations.
Information provided in these operating instructions
These operating instructions describe the ATMOS Chair 41 Gyne purposes and provide information on how it works, its functions, maintenance, trouble shooting and relative solutions.
Marks and symbols
The following marks and symbols are being used in this handbook:
Note: This points out, that the text contains some important information.
Attention: This message may appear before certain procedures. If it is ignored, the equipment could be damaged.
Warning: This message may appear before certain procedures. If it is ignored, the operator could be injured and
the equipment damaged.
General information
The ATMOS Chair 41 Gyne does not electromagnetically or otherwise a󰀨ect other equipment nor is the chair itself a󰀨ected by these phenomena,
caused by other equipment, as it is manufactured in compliance with the Directive, and meets the requirements of the harmonised standard EN 60601-1:1996-03.
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1.0 Introduction
1.1 Intended use
Name: ATMOS Chair 41 Gyne
Main functions: Examinations and therapy in the gynaecological sector
Med. indications/ application: Direct contact with the skin exclusively with the prescribed / recommended paper
Specicationofthe Positioning and bedding of the patient for gynaecological
main function: examination and treatment like pap smear test, colposcopy, diagnostic hysteroscopy, conus biopsy, intravaginal and abdominal echography
Application organ: Female sexual / reproductive organs
Application time: Temporary
Application site: In gynaecologist clinics and practices
Contraindications: Not to be used outside medical areas: Device must not be
used in areas with a potential explosive hazard in
rooms specied for medical treatment.
The product is: active
Sterility: Not necessary
Single use product / No single use product reprocessing:
1.2 For your safety
- Max. patient weight: 150 kg
- Max. lifting capacity: 200 kg
- Prior to cleaning, the mains switch must be switched o󰀨.
- The ATMOS Chair 41 Gyne may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments.
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1.0 Introduction
This chapter describes the features of the gynaecological chair ATMOS Chair 41 Gyne. The main equipment components and relative accessories are also illustrated.
Warning:
This equipment has been conceived for gynaecology purposes only. Neither the chair nor its components
mustbemodiedwithoutpriorwrittenauthorisation.
Warning:
It must not be used for purposes other than gynaecological ones (especially not in operating theatres).
Warning:
When moving the chair make sure that the patient has her hands at the chair and that third persons and things are in adequate distance from the chair.
The ATMOS Chair 41 Gyne has the following features:
• The chair has a driven backrest adjustment for the Trendelenburg position and a lift mechanism.
1.3 MAIN CHARACTERISTICS
The ATMOS Chair 41 Gyne o󰀨ers the following features:
• perfectly symmetrical chair;
• 3 user speciable position memory systems;
• auto return system to “zero” position;
• control pedals reextractable from the base;
• Trendelenburg position;
• liquid collection basin, plastic or stainless steel (optional);
• leg section extension built in the chair (optional);
• leg rests, adjustable (optional);
• seamless chair upholstery;
• handles; (optional)
• magnetic head-rest cushion (optional);
• paper roll holder integrated in the chair back;
• removable foot rest for the doctor (optional);
• step for helping the patient get on the chair;
• double electrical socket in the base (230 V) Attention: max. load is 460 W! (optional)
• low voltage controls (5 V).
Warning:
During the Trendelenburg movement the patient must grasp the handles and have a support for the shoulders.
Warning:
During an anaesthesia, an assistant must attend for safety reasons.
Warning:
When several devices are connected to one socket, the allowed load and leakage currents must be observed.
Note:
In order to ensure the proper functioning of the position memory system, it is highly recommended to reset the chair to “zero” position by pressing key “0”, after every medical visit.
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1.0 Introduction
1.4 Type label
The type label is situated on the rear part of the chair and indicates the model, the serial number, the REF and other information (see Fig. 1.1).
1.5 Technical information
Fig. 1.1
Fig. 1.2
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2.0 Scope of supply
For removing the packing, all screws must be loosened and the strap must be removed.
The following components must be supplied inside the packing of the bottom part:
• 1 bottom part of the ATMOS Chair 41 Gyne
• 1 operating instructions
• 1 bottle of detergent
• 1 power supply cable
• 1 guarantee certicate
The following must be supplied inside the packing of the upper part:
• 1 upper part of the ATMOS Chair 41 Gyne
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3.0 Setting up and starting up
Loosen the two screws that secure the chair to the wooden pallet to free it. A second person is required to help to move the chair from the pallet. Use the transport handles to move the chair. Use the lateral handles at the seat to position the upper part onto the lower part.
1) Place the upper part of the chair on top of the lower part, matching the xing holes of the seat support with the xing holes of the counter seat, as shown in the gure.
2) Fix the upper part and the lower part by means of the screws provided.
3) Connect the orange 4 poles crimping terminal of the seat support (Fig. 3.1 A) with that of the counter seat (Fig. 3.1 B) for the mains power supply of the backrest and the respective micro switch.
Fig 3.1
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3.0 Setting up and starting up
Once the two parts of the chair have been assembled and placed in the desired position, securing it, if necessary to the
oor, exploiting the holes in the base (see Fig. 3.2), proceed as follows:
1. Remove the handles used to move the chair.
2. Make sure that the place in which the chair is installed is provided with a suitable earth system.
3. Make sure that the voltage of the electrical power supply system of the place in which the chair is installed corresponds to that indicated on the type label.
4. Make sure that the fuses on the back of the chair are tted rmly as they could have loosened during transport.
5. Plug the power supply cable into the socket in the chair base and then into the mains socket.
6. Turn the chair on by pressing the main ON/OFF switch.
The chair is now ready to be used. If it should fail to work, see chapter 7.0 Trouble shooting.
Warning:
Thetwosocketssituatedinthebasemayonlybeusedwhenthechairissecuredtotheoor.
Note:
If the mains power supply socket is situated at oor level, pit A (Fig. 3.2) in the chair base may be exploited, then feed the
power supply cable in, through the panels exploiting the appropriate groove.
Attention:
Inthiscasethechairmustbesecuredtotheoor.
640
250
105
240
420
A
550
10
2 holes ø = 10 mm
300
980
Fig. 3.2
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4.0 Operation
Thanks to the integrated control electronics, the chair has many functions, which are easy to use. All the chair adjustments and functions are co-ordinated, processed and stored by an integrated microprocessor. The ATMOS Chair 41 Gyne can easily be controlled when using the foot pedal, with it the gynaecologist has his hands free for the patient.
Warning:
Make sure that the chair has been correctly installed before putting the information provided in this section of the operating instructions into practice (see chapter 3).
4.1 Controls
The chair has the following control elements:
Left-hand foot pedal (Fig. 4.1):
• Up arrow “↑” - upward movement of chair
• Down arrow “↓” - downward movement of chair
• Right-hand arrow “→” - Trendelenburg position -10˚
• Left-hand arrow “←” - Trendelenburg position +25˚
RH FOOT PEDAL CONTROL (Fig. 4.1)
• Up arrow “↑” - upward movement of chair
• Down arrow “↓” - downward movement of chair
• Right-hand arrow “→” - downward tilt of chair back
• Left-hand arrow “←” - upward tilt of chair back
• “0” - Automatic return to “zero” position.
• “I” - Program 1 (position memory)
• “II” - Program 2 (position memory)
• “III” - Program 3 (position memory)
Keep pressed the key for activating the relevant movement. A short key press activates the position memory.
The electronics requires a short delay of approx. 0.5 sec to di󰀨erentiate between "short key press" and "keep depressed". Therefore, not e󰀨ort but patience is required.
Left Right
Fig. 4.1
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4.0 Operation
Warning:
When moving the chair make sure that the patient has her hands at the chair and that third persons and things are
in adequate distance from the chair.
4.2 Programming
Proceed as follows to program (keys “I”,”II” and “III” of the right-hand foot pedal):
1. Bring the chair into basic position by pressing the "0" key shortly.
2. Bring the chair into the requested position.
3. Keep depressed the programming switch M, which is on the “cover”, on the left of the lifting mechanism and lightly press key “I”, “II” or ”III” depending on the requested storage place.
4. An acoustic signal (beep) conrms successful saving.
4.3 Leg rest adjustment
Proceed as follows to move the leg rest:
Hold the patient’s leg with one hand, loosen handle 1 and adjust the height of the leg rest. When the required position is reached, tighten handle 1 again.
To adjust the positionable leg rest 2, loosen handle 3, move the leg rest to the required position and retighten handle 3.
4.4 Leg rest (REF 503.0552.0)
For extracting the leg rest: Catch the leg rest in centre between seat and secretion bowl. Now pull out the leg rest until it is on the same level like the seat.
2
1
3
Fig 4.2
When pulling the leg rest in: ATTENTION! Do not touch the guiding rail of the leg rest (see Fig. 4.3). There is a risk of injury!
Grasp the centre of the leg support. With the other hand grasp the metal bar under the leg support and hold it tight. Now slide the support back until it declines. As soon as the leg support declines, take your hand from the metal bar and slide the support backwards until it snaps in.
12
Fig 4.3
Page 13
5.0 Cleaning and care
In case the chair is left inoperative for a longer period, it is advisable to cover it with a sheet, to switch it o󰀨 and disconnect it
from the mains supply.
5.1 Cleaning
For a longer service life, cleaning with a wet cloth is recommended at regular intervals.
Upholstery
For removing stains on the upholstery, only the supplied detergent may be used. For cleaning a soft cloth must be used to
prevent supercial cracks and to ensure the exibility and softness of the material.
Substances such as blood need to be removed immediately to prevent stains on the cover material of the upholstery.
Note: Please reorder the detergent once it is used up.
Parts made of polyurethane
The parts made of polyurethane must be cleaned using a cloth soaked in soapy water.
Painted parts
The painted parts must be cleaned using a cloth soaked in soapy water.
Attention:
Please do not use substances, detergents and strong abrasives for cleaning, and even not for removing tenacious stains.
Furthermore please take care when using colour-intensive substances, like, for example, Betaisodona, as this may lead to discolourations and unattractive stains.
5.2 Paper roll replacement
Proceed as follows to replace the paper roll (see Fig. 5.1):
1. Bring the chair back into horizontal position.
2. Remove the chair back upholstery from the chair back.
3. Block the upholstery using the appropriate locking device integrated in the chair back.
4. Extract the tube support from the chair back.
5. Insert the tube support in the new paper roll.
6. Position the roll in the chair back, running the end of paper upwards.
7. Close the upholstery, making sure that the paper is fed out from the chair back.
Warning:
The manufacturer cannot be hold liable for any damages that may occur from the non-observance of the regulations
stated in these operating instructions.
The function of the roll paper feed can be guaranteed only when using the original paper roll (REF 503.0557.0).
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5.0 Cleaning and care
Fig 5.1
5.3 Recommended surface disinfectants
The surfaces of the Chair 41 Gyne can be cleaned with disinfectants with the following active ingredients:
• quaternary ammoniumchlorides
5.3.1 Recommended disinfectant for cushion
Disinfectant Contents (in 100 g) Manufacturer
Green & Clean SK Alkyldimethylbenzylammoniumchloride < 1 g Metasys, Rum (Ausrtia)
(Application concentrate) Dialkyldimethylammoniumchloride-
Ammoniumchloride
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6.0 Maintenance and servicing
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 una󰀨ected.
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 specications.
6.1 Exchange of upholstery
Seat upholstery
This upholstery is xed with nylon snap fasteners and can therefore easily be removed in pulling it o󰀨. If required, adjust the lower and the upper snap fastener for a perfect t of the upholstery.
Back upholstery
This upholstery is xed with magnets and nylon snap fasteners. For removing the upholstery, loosen the xation screws of the upholstery support, which is xed at the hinges near the seat.
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7.0 Trouble-shooting
Problem Check Trouble shooting The chair
cannot be moved
Problem Check Trouble shooting Foot control
pedal does not work properly
Mains cable is connected? Connect the mains cable to the mains supply. Main switch is on? Switch on the mains switch. Is the green control lamp illuminated? Check the fuses, 2 pieces 3,15 A, at the power input.
Is the green LED on the board "PWR" Check the connector on the board. Fuse on the board
switched on and is a beep audible T 315 mA and T 12,5 A. during switch on? Check the fuse F 12,5 A between transformer and board.
Voltage at the plug CN9 Fuse between transformer and board F 12,5 A or (24–28 V AC on the board exchange transformer. near the small transformer)
Observe operating instructions. Press the control pedal straight and not skewed. In order not to twist the pedal, observe the delay regarding the position memory.
Despite perfect operation, the foot control pedal Exchange the board in the foot pedal and check perfect pass
does not always work properly. of the cable, the way the cover ts perfectly.
Problem Check Trouble shooting Chair only
moves upwards and then it stops
Problem Check Trouble shooting Chair can
be moved but position storage is not possible
Problem Check Trouble shooting Trendelen-
burg motor does not work
Problem Check Trouble shooting Deviation
from the chair position stored
Does the relay on the board work properly? If not, exchange the board.
Measure the voltage at the motor (24 – 28 V AC). If voltage is connected and the motor does not work, exchange the motor.
Check the connector on the board. Rectify the fault (exchange the connector or the board).
Check the button for position memory. If required, exchange the switch.
Does the relay on the board work properly? If not, exchange the board. Measure the voltage at the motor (24 – 28 V AC). If voltage is connected and the motor does not work,
exchange the motor.
Correct adjustment of requested position? Bring the chair into "0" position, then adjust the requested
position and store it, as described in the operating instructions.
Problem Check Trouble shooting Motor
makes noises
Loud cracking and sometimes the Probably the gear mechanism is defective, therefore motor does not work. exchange the motor.
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8.0 Accessories, further options and consumables
Accessories
Headrest magnetic pillow
Colour: Pastel blue Colour: Saffron yellow Colour: Salmon Colour: Leaf green Colour: Light grey Colour: Silk grey Colour: White Colour: Sapphire blue
Leg support all-cushion 1 pairr
Colour: Pastel blue Colour: Saffron yellow Colour: Salmon Colour: Leaf green Colour: Light grey Colour: Silk grey Colour: White Colour: Sapphire blue
Leg support stainless steel
1 pair, with cushion, foot support plate stainless steel
Colour: Pastel blue Colour: Saffron yellow Colour: Salmon Colour: Leaf green Colour: Light grey Colour: Silk grey Colour: White Colour: Sapphire blue
Leg holders „Goepel“
1 pair, without cushion, simultaneous adjustment of height, inclination and distance
Cushion for leg holders „Goepel“
Colour: Pastel blue Colour: Saffron yellow Colour: Salmon Colour: Leaf green Colour: Light grey Colour: Silk grey Colour: White Colour: Sapphire blue
Handles, 1 pair, high-grade steel
REF
503.0556.0
503.0556.1
503.0556.2
503.0556.3
503.0556.4
503.0556.5
503.0556.6
503.0556.7
503.0558.0
503.0558.1
503.0558.2
503.0558.3
503.0558.4
503.0558.5
503.0558.6
503.0558.7
503.0554.0
503.0554.1
503.0554.2
503.0554.3
503.0554.4
503.0554.5
503.0554.6
503.0554.7
503.0551.0
503.0565.0
503.0565.1
503.0565.2
503.0565.3
503.0565.4
503.0565.5
503.0565.6
503.0565.7
503.0573.0
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8.0 Accessories, further options and consumables
Accessories
Leg rest
extendable, width 440 mm (complete length 1970 mm)
REF
503.0552.0
Secretion Basin, Plastic
To be pulled out, tiltable storage
Secretion basin stainless steel for the attachment kit (REF 503.0571.0) 325 x 265 mm, height 65 mm, additional price
Docotor´s foot support
Examination stool
height adjustable, safety chassis on 5 double castors
Colour: Pastel blue Colour: Saffron yellow Colour: Salmon Colour: Leaf green Colour: Light grey Colour: Silk grey Colour: White Colour: Sapphire blue
503.0571.0
503.0555.0
503.0559.0
503.0570.0
503.0570.1
503.0570.2
503.0570.3
503.0570.4
503.0570.5
503.0570.6
503.0570.7
18
Colposcope holder
mountable left or right, for colposcope für ATMOS i View Kaps support with tube diameter from 30 - 38 mm;
Consumables for the ATMOS Chair 41 Gyne
Paper role
503.0553.0
503.0557.0
Page 19
9.0 Technicalspecications
Nominal voltage 230 V ± 10% Nominal frequency 50-60 Hz Fuses 2 × T 3.15 A 250 V Control voltage 5 V Motor voltage 24 V
Conditions Transport and Storage
max. seat height (mm) 900 min. seat height (mm) 570 Width (mm) 677 Length (mm) 1970 Trendelenburg (degree) -10 + 25 Tilt of back rest (degree) 0 ÷ 70 Net weight (kg) 200 Dimensions packing (mm) 800 x 1360 x 845
max. lift (kg) 150 max. lifting weight 200 kg Protection class (EN 60601-1) I Degree of protection type B
Classication according to appendix IX
EC Directive 93/42/EEC
Applied standards EN 60601-1: 1996-03 Type of application discontinuous (18 sec ON - 340 sec OFF) UMDNS-Code 10-960 GMDN-Code 38447
+10...+35°C
20...80 % atmospheric pressure from
500...1060 hPa
800 x 1360 x 365
I
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10.0 Disposal
The ATMOS Chair 41 Gyne is not comprised of any hazardous materials.
The materials of the housing can be recycled completely.
Prior to disposal, device and accessories must be decontaminated.
The materials are to be separated carefully.
Pay attention to country-specic regulations for disposal (e. g. waste incineration).
Disposal within the EC
The product described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professional. 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.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) rules 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.
Disposal of the packing
All the materials used to pack the chair respect the environment and are 100% recyclable:
- untreated wooden pallet,
- carton,
- polyethylene bag,
- bubble-pack polyethylene.
The recovery and recycling of the materials used to pack the chair help to save on raw materials and to reduce waste volumes. Hand the packing over to a disposal company that is authorised to recover recyclable materials.
Disposal of the chair
Once the chair has reached its expected lifetime and before it is nally disposed of, it must be made unusable by unplugging it
from the mains socket and cutting the power supply cable.
The chair disposal does not involve any hazard whatsoever.
For the correct safeguard of the environment, hand the unserviceable chair over to a disposal company that is authorised to recover recyclable and non-recyclable materials.
Themanufacturercanonlybeholdliableintermsofchairsafety,reliabilityande󰀩ciencyprovidedthat:
• the chair has been installed, adjusted and repaired by personnel authorised by the manufacturer;
• the electrical system of the place in which the chair is installed complies with current standards;
• the equipment is used in compliance with the operating instructions.
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11.0 Notes on EMC
Guidelines and Manufacturer´s Declaration - Emissions
The ATMOS Chair 41 Gyne is intended for use in the electromagnetic environment specied below. The customer or user of the ATMOS Chair 41 Gyne should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions CISPR 11
RF Emissions CISPR 11
Group 1
Class B
Harmonics IEC 61000-3-2 Class B
Flicker IEC 61000-3-3
complies
The ATMOS Chair 41 Gyne 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.
The ATMOS Chair 41 Gyne is suitable for use in all establishments, including domestic, and those directly connected to the public low­voltage power supply network that supplies buildings used for domestic purposes.
Guidelines and Manufacturer´s Declaration - Immunity for ATMOS Chair 41 Gyne The ATMOS Chair 41 Gyne is intended for use in the electromagnetic environment specied below. The customer or user of the ATMOS Chair 41 Gyne should ensure that it is used in such an environment.
Immunity Test
ESD IEC 61000-4-2
EFT IEC 61000-4-4
IEC 60601­Test Level
± 6 kV Contact
± 8 kV Air ± 2 kV Mains
Compliance Level
± 4 kV Contact
± 8 kV Air ± 1 kV Mains Mains power quality should be that of a typical
Electromagnetic Environment ­Guidance
Floors should be wood, concrete, or ceramics
tile. If oors are synthetic, the relative humidity
should be at least 30%.
commercial or hospital environment.
± 1 kV I/Os
Surges IEC 61000-4-5
± 1 kV symmetric
± 1 kV symmetric
Mains power quality should be that of a typical commercial or hospital environment.
Voltage Dips / Dropout IEC 61000-4-11
Power Frequency 50/60
Hz Magnetic eld
IEC 61000-4-8 NOTE U
is the mains alternating current prior to application of the test levels.
T
± 1 kV for input and
not applicable
output power < 5 % U
(> 95 % Dip of the UT) for 0.5 Cycle
T
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS Chair 41 Gyne demands continued function even in case of interruptions
40 % U
T
(60% Dip of the UT) for 5 Cycles
70% U
T
(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
40 % U
T
(60% Dip of the UT) for 5 Cycles
70% U
T
(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
of the energy supply, it is recommended to supply the ATMOS Chair 41 Gyne from an uninterruptible current supply or a battery.
3 A/m not applicable Power frequency magnetic elds should be that
of a typical commercial or hospital environment.
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11.0 Notes on EMC
Guidelines and manufacturer's declaration – Electromagnetic noise immunity –
for devices and system which are not life-sustaining
The ATMOS Chair 41 Gyne is intended for use in the electromagnetic environment specied below. The customer or user of the ATMOS Chair 41 Gyne should ensure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601­Test Level
= 3 Ve󰀨
V
1
150 kHz bis 80 MHz
= 3 V/m
E
1
80 MHz bis 2,5 GHz
Compliance Level
3 V
3 V/m
Electromagnetic Environment ­Guidance
Portable and mobile communications equipment should be separated from the ATMOS Chair 41 Gyne incl. the cables by no less than the distances calculated/listed below.
Recommended distances
d = (3,5 / V
d = (3,5 / E
d = (7 / E
) * √(P)
1
) * √(P)
1
) * √(P)
1
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.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines are not applicable in any case. The propagation of electromagnetic sizes is
inuenced by absorptions and reections of buildings, objects and people.
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11.0 Notes on EMC
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 Chair 41 Gyne is used exceeds the above compliance level, the ATMOS Chair 41 Gyne 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 is to be below 3 V/m.
Recommended separations between portable and mobile RF communications
equipment and the ATMOS Chair 41 Gyne
The ATMOS Chair 41 Gyne is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS Chair 41 Gyne can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS Chair 41 Gyne as recommended below, according to the maximum output power of the communications equipment.
Nominal output of the
transmitter
in Watts (W)
0,01 0,116 0,116 0,233
0,1 0,367 0,367 0,737 1,0 1,16 1,16 2,33
10 3,67 3,67 7,37
100 11,67 11.67 23,33
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended separation 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 specication.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines are not applicable in any case. The propagation of electromagnetic sizes is inuenced by absorptions and reections of buildings, objects and people.
Separation distance, depending on transmit-frequency m
150 kHz - 80 MHz
d = (3,5/V
) * √(P)
1
80 MHz - 800 MHz
d = (3,5/E1) * √(P)
800 MHz - 2,5 GHz
d = (7/E1) * √(P)
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ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch / Germany
Phone: +49 7653 689 -0
atmos@atmosmed.de
www.atmosmed.com
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