Chair 41 Gyne Operating Instructions Index 19 Nov 2015

Table of contents

ATMOS

MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch Deutschland/Germany Telefon: + 49 7653 689-0 Fax: + 49 7653 689-392 (Sales Germany) + 49 7653 689-391 (Export Sales) e-mail: [email protected] Internet: http://www.atmosmed.de 2

1.0 1.1 1.2 1.3 1.4 1.5

Introduction... 5-7 Intended use... 5 For your safety... 5 Main characteristics... 6 Type label... 7 Technical information... 7

2.0

Scope of supply... 8

3.0

Setting up and starting up... 9-10

4.0 4.1 4.2 4.3 4.3

Operation... 11-12 Controls...11 Programming... 12 Leg rest adjustment... 12 Leg rest (REF 503.0552.0)... 12

5.0 5.1 5.2 5.3 5.3.1

Cleaning and care... 13-14 Cleaning... 13 Paper roll replacement... 13-14 Recommended surface disinfectants... 14 Recommended disinfectant for cushion... 14

6.0 6.1

Maintenance and servicing... 15 Exchange of upholstery... 15

7.0

Trouble shooting... 16

8.0 8.1 8.2 8.3

Accessories, further options, consumables... 17-18 Accessories... 17-18 Further options... 17-18 Consumables... 18

9.0

Technical specifications... 19

10.0

Disposal... 20

11.0

Notes on EMC... 21-23

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

3

1.0

Introduction These operating instructions contain important notes on how to operate the ATMOS Chair 41 Gyne safely, correctly and effectively. 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 certified 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 affect other equipment nor is the chair itself affected 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.

4

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

Specification of the main function:

Positioning and bedding of the patient for gynaecological 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 specified for medical treatment.

The product is:

active

Sterility: Not necessary Single use product / reprocessing:

No single use product

1.2 For your safety - Max. patient weight: 150 kg - Max. lifting capacity: 200 kg - Prior to cleaning, the mains switch must be switched off. - 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.

5

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 modified 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 offers the following features: • perfectly symmetrical chair; • 3 user specifiable 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.

6

1.0 1.4

Introduction 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).

Fig. 1.1

1.5

Technical information

Fig. 1.2

7

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 certificate The following must be supplied inside the packing of the upper part: • 1 upper part of the ATMOS Chair 41 Gyne

8

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 fixing holes of the seat support with the fixing holes of the counter seat, as shown in the figure.

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 floor, 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 fitted firmly 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 floor. Note: If the mains power supply socket is situated at floor 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 floor.

A

420

250

240

550

105

640

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 “↑” • Down arrow “↓” • Right-hand arrow “→” • Left-hand arrow “←”

- upward movement of chair - downward movement of chair - Trendelenburg position -10˚ - 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 differentiate between "short key press" and "keep depressed". Therefore, not effort but patience is required.

Left

Right

Fig. 4.1

11

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) confirms successful saving.

4.3

Leg rest adjustment

2

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.

1

3

Fig 4.2

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. 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. Fig 4.3

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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 off 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 superficial cracks and to ensure the flexibility 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. 2. 3. 4. 5. 6. 7.

Bring the chair back into horizontal position. Remove the chair back upholstery from the chair back. Block the upholstery using the appropriate locking device integrated in the chair back. Extract the tube support from the chair back. Insert the tube support in the new paper roll. Position the roll in the chair back, running the end of paper upwards. 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

Green & Clean SK

Alkyldimethylbenzylammoniumchloride DialkyldimethylammoniumchlorideAmmoniumchloride

(Application concentrate)

14

(in 100 g) <1g

Manufacturer Metasys, Rum (Austria)

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 unaffected. 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 specifications.

6.1

Exchange of upholstery

Seat upholstery This upholstery is fixed with nylon snap fasteners and can therefore easily be removed in pulling it off. If required, adjust the lower and the upper snap fastener for a perfect fit of the upholstery. Back upholstery This upholstery is fixed with magnets and nylon snap fasteners. For removing the upholstery, loosen the fixation screws of the upholstery support, which is fixed at the hinges near the seat.

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7.0

Trouble-shooting

Problem

Check

Trouble shooting

The chair cannot be moved

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" switched on and is a beep audible during switch on?

Check the connector on the board. Fuse on the board T 315 mA and T 12,5 A. Check the fuse F 12,5 A between transformer and board.

Voltage at the plug CN9 (24–28 V AC on the board near the small transformer)

Fuse between transformer and board F 12,5 A or exchange transformer.

Problem

Check

Trouble shooting

Foot control pedal does not work properly

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 does not always work properly.

Exchange the board in the foot pedal and check perfect pass of the cable, the way the cover fits perfectly.

Problem

Check

Trouble shooting

Chair only moves upwards and then it stops

Does the relay on the board work properly?

Measure the voltage at the motor (24 – 28 V AC). If voltage is connected and the motor does not work, exchange the motor.

Problem

Check

If not, exchange the board.

Trouble shooting

Chair can Check the connector on the board. be moved but position storage is Check the button for position memory. not possible

Rectify the fault (exchange the connector or the board).

Problem

Check

Trouble shooting

Trendelenburg motor does not work

Does the relay on the board work properly?

If not, exchange the board.

Problem

Check

Deviation from the chair position stored

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 motor does not work.

Probably the gear mechanism is defective, therefore exchange the motor.

16

If required, exchange the switch.

Measure the voltage at the motor (24 – 28 V AC). If voltage is connected and the motor does not work, exchange the motor.

Trouble shooting

8.0 Accessories, further options and consumables REF

Accessories









 Headrest magnetic pillow Colour: Pastel blue

503.0556.0

Colour: Saffron yellow

503.0556.1

Colour: Salmon

503.0556.2

Colour: Leaf green

503.0556.3

Colour: Light grey

503.0556.4

Colour: Silk grey

503.0556.5

Colour: White

503.0556.6

Colour: Sapphire blue

503.0556.7

 Leg support all-cushion 1 pairr Colour: Pastel blue

503.0558.0

Colour: Saffron yellow

503.0558.1

Colour: Salmon

503.0558.2

Colour: Leaf green

503.0558.3

Colour: Light grey

503.0558.4

Colour: Silk grey

503.0558.5

Colour: White

503.0558.6

Colour: Sapphire blue

503.0558.7

 Leg support stainless steel 1 pair, with cushion, foot support plate stainless steel Colour: Pastel blue

503.0554.0

Colour: Saffron yellow

503.0554.1

Colour: Salmon

503.0554.2

Colour: Leaf green

503.0554.3

Colour: Light grey

503.0554.4

Colour: Silk grey

503.0554.5

Colour: White

503.0554.6

Colour: Sapphire blue

503.0554.7

 Leg holders „Goepel“ 1 pair, without cushion, simultaneous adjustment of height, inclination and distance

503.0551.0

Cushion for leg holders „Goepel“



Colour: Pastel blue

503.0565.0

Colour: Saffron yellow

503.0565.1

Colour: Salmon

503.0565.2

Colour: Leaf green

503.0565.3

Colour: Light grey

503.0565.4

Colour: Silk grey

503.0565.5

Colour: White

503.0565.6

Colour: Sapphire blue

503.0565.7

 Handles, 1 pair, high-grade steel

503.0573.0

17

8.0 Accessories, further options and consumables 

REF

Accessories  Leg rest extendable, width 440 mm (complete length 1970 mm)

503.0552.0

 Secretion Basin, Plastic To be pulled out, tiltable storage

503.0571.0

Secretion basin stainless steel for the attachment kit (REF 503.0571.0) 325 x 265 mm, height 65 mm, additional price

503.0555.0



 Docotor´s foot support

503.0559.0



 Examination stool height adjustable, safety chassis on 5 double castors





Colour: Pastel blue

503.0570.0

Colour: Saffron yellow

503.0570.1

Colour: Salmon

503.0570.2

Colour: Leaf green

503.0570.3

Colour: Light grey

503.0570.4

Colour: Silk grey

503.0570.5

Colour: White

503.0570.6

Colour: Sapphire blue

503.0570.7

 Colposcope holder mountable left or right, for colposcope für ATMOS i View Kaps support with tube diameter from 30 - 38 mm;

503.0553.0

Consumables for the ATMOS Chair 41 Gyne Paper role

18

503.0557.0

9.0

Technical specifications

Nominal voltage

127 V ± 10%

Nominal frequency

50-60 Hz

Fuses

2 × T 6.3 A 250 V

Control voltage

5V

Motor voltage

24 V

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 845 800 x 1360 x 365

max. lift

(kg)

150

max. lifting weight

200 kg

Protection class (EN 60601-1)

I

Degree of protection

type B

Classification according to appendix IX EC Directive 93/42/EEC

I

Applied standards

EN 60601-1: 1996-03

Type of application

discontinuous (18 sec ON - 340 sec OFF)

UMDNS-Code

10-960

GMDN-Code

38447

19

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-specific 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 finally 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 efficiency 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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