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Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A

These instructions for use

General

These instructions for use refl ect the state of knowl-
edge at the time of printing and make no claim to
completeness. The information provided in these
instructions for use may be outdated due to the
ongoing technical development of our products.
However, all information is regularly updated in
revisions.
Illustrations in these instructions for use are not
necessarily to scale.
Keep these instructions for use at the place of use of
the product.

These instructions for use must be read and
observed by all persons who use, operate or clean
the product.
To be able to use the described product safely, the
provisions of these instructions for use must be
observed. Please observe in particular warnings,
ambient conditions, installation instructions, oper-
ating instructions, inspection and maintenance
regulations, as well as the standards listed in these
instructions for use.

Warnings

A risk assessment pursuant to ISO 14971:2007+
amendment:2009 (Risk management for medical
devices) was performed for this device. The signal
words, symbols and colours of the warnings were
selected in accordance with ANSI 535.6.
The warnings were scaled in accordance with the
following defi nitions for risk assessment.

DANGER!

“DANGER” refers to a hazardous situation which
could result in serious injury or death if it is not
avoided. Serious injuries are irreversible injuries
requiring permanent and regular medical care.

WARNING!

“WARNING” refers to a hazardous situation which
could result in moderate to serious injury if it is not
avoided. This includes reversible injuries requiring
care or examination by a medical professional.

CAUTION!

“CAUTION” refers to a hazardous situation which
could result in slight to moderate injury if it is
not avoided. This includes reversible injuries not
requiring medical care.

NOTE

“NOTE” refers to information not relating to personal
injury, e.g. information relating to damage to prop-
erty.

RECOMMENDATION

Recommendations are information that helps readers
use the product better, longer and more safely.

Text symbols

A triangle before the text means:



Execute this work step.



Execute this partial work step.

A square before the text means:



This is the result of the previous action.

A bullet point before the text means:

•

This is part of an itemisation.

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Содержание 114.9600.0

Страница 1: ...Instructions for use Examination and treatment chair arco matic 200 M 300 M arco matic 114 9600 0 arco matic 114 9700 0...

Страница 2: ...tial equalisation optional 101 0481 0 26 Sockets on the device optional 101 0482 0 27 Positioning patients 29 Operation 30 Safety information 30 Switching on off 31 Hand control unit 32 Foot control u...

Страница 3: ...echnical Service 66 Wear parts 67 Visual and functional checks 67 Disposal 69 Product identification 70 Identification plate 70 Symbols used 71 Technical data 73 Connection dimensions 76 EMC declarati...

Страница 4: ...l devices was performed for this device The signal words symbols and colours of the warnings were selected in accordance with ANSI 535 6 The warnings were scaled in accordance with the following defin...

Страница 5: ...ith requirements Non slip setup Before and during use of the product it must be ensured that the product has sufficient floor adhe sion and that there is good slip resistance for both product and user...

Страница 6: ...ir arco matic is intended for use in human medicine only The examination and treatment chair may be used for the following purposes for the short term positioning of patients for urological examinatio...

Страница 7: ...on the G pel leg support 101 0475 0 Protective covers pair to protect the foot supports when used with shoes 101 0482 0 2 sockets as power supply for accessories attached to the examination and treat...

Страница 8: ...ries 25 0 6 101 0468 0 Foot rest for the doctor to support the doctor s feet during the examination right sided version 25 1 5 101 0469 0 Foot rest for the doctor to support the doctor s feet during t...

Страница 9: ...tion and treatment chair arco matic 200 M 300 M Head pad Head cushion optional 101 0472 0 Back pad Leatherette cladding Seat pad Lifting arm Rear foot section cladding Foot supports Rinsing basin Foot...

Страница 10: ...M back Locking pedal optional On off switch Fine wire fuses of the inte grated sockets Attachment screws for the rear foot section cladding Screw thread for the attach ment screws Cable brackets Inte...

Страница 11: ...mm in a longitudinal direction and 250 mm in a transverse direction During the adjustment of the examination and treat ment chair the rinsing basin remains in a horizontal position automatically It me...

Страница 12: ...quipped with a memory for four adjustable chair positions memory function Adjustment functions operated by electric motors are activated by a foot control unit or hand control unit For more informatio...

Страница 13: ...ctronic control unit may be damaged irreparably during storage or transport Hence the examination and treatment chair must not be exposed to conditions other than those indicated during transport and...

Страница 14: ...fter delivery transport the product to its place of use in its original packaging Unpacking NOTE The pads of the examination and treatment chair can easily be slit when cutting open the packaging film...

Страница 15: ...rted at the destination Remove the attached foot supports Keep the right and left foot supports separately Each is to be fitted on the other side respectively once the examination and treatment chair...

Страница 16: ...the product to its lowest position During transportation ensure that the unit does not collide with persons or objects Setup NOTE The examination and treatment chair requires some time to acclimatise...

Страница 17: ...spanner and a bar Levelling The levelling feet serve to compensate for uneven floors and to ensure that the examination and treat ment chair is placed in a horizontal position Lift the examination and...

Страница 18: ...e completely disconnected from the mains supply during such work If setting up an electrical hardwired connection for the examination and treatment chair a wall switch must be installed which can swit...

Страница 19: ...e on site electrical connection through the opening in the control unit housing as shown in Fig 15 Connect the conductors of the new mains cable to the mains socket as shown in Fig 13 Put the cover ba...

Страница 20: ...rear foot section cladding Fig 16 Mounting the rear foot section cladding 1 Rear foot section cladding 2 Recess 3 Power cord Insert two attachment screws for the rear foot section cladding into the b...

Страница 21: ...able 1 Screw locking device of the power cord 2 Screw thread of the power cord 3 Attachment screw Insert the socket cladding and press down firmly Insert the attachment screws and tighten with the M2...

Страница 22: ...Connect the mains connection cable to the mains supply Switch on the examination and treatment chair using the on off switch Elevate the examination and treatment chair to the highest position see Tab...

Страница 23: ...ting cable 4 Foot control unit Fig 24 Connecting the foot control unit 1 Connector socket 2 Connector plug 3 Connecting cable 4 Foot control unit The connector plug features a nose Turn the connector...

Страница 24: ...n the collar of the front foot section cladding the cladding of the examination and treatment chair will be damaged when the seat pad is lowered Hence ensure that the panel can slide without obstructi...

Страница 25: ...onnect the plug of the connection cable to the hand control unit Fig 29 Connect the plug of the connection cable to the hand control unit 1 Plug of connection cable to hand control unit Insert the loc...

Страница 26: ...y be damaged if the incorrect mains voltage is connected The mains voltage and mains frequency of the connected voltage supply must correspond to the voltage indicated on the identification plate of t...

Страница 27: ...the mains plug make sure that the devices connected to the integrated sockets are safe to operate For example examination lights and video colpo scopes can be connected to the integrated sockets on th...

Страница 28: ...cket Fig 35 Installing the cables 1 Cable brackets Replace the socket cladding Fig 36 Fitting the socket cladding and fuses 1 Socket cladding 2 Retaining pin 3 Retaining clips Reinsert the attachment...

Страница 29: ...f the examination and treatment chair is used in combination with HF surgical devices and defibrillator devices Use electrically insulated underlays between the patient and the examination and treatme...

Страница 30: ...adjustment the examination chair or the accessories mounted on it e g G pel leg support may collide with body parts or other objects leading to personal injury or property damage Make sure that there...

Страница 31: ...ts that apply with regard to the ambient conditions To view the list of ambient conditions permitted for operation please see Tab 6 Ambient condition Value Ambient temperature 5 C 40 C Relative humidi...

Страница 32: ...button lower seat section Adjustment button lower foot support Indicator light memory position 3 Adjustment button raise seat section Adjustment button raise foot support Memory button move to memory...

Страница 33: ...ng buttons adjustment buttons and memory buttons For an overview of the various functions see Fig 39 The adjustment buttons adjust the examination and treatment chair as long as the adjustment button...

Страница 34: ...ion chair Press the adjustment button Raises the foot supports of the exam ination chair only available on arco matic 300 M Press the adjustment button Lowers the foot supports of the exam ination cha...

Страница 35: ...vely the patient can be put into the hori zontal position as shown in Fig 41 Fig 41 Example 2 Example of an adjustment shock position CAUTION In the event of an unexpected movement into the shock posi...

Страница 36: ...yellow not applicable Controller reset press and hold buttons 1 and 2 on the hand control unit together for approx 5 seconds If the warning light continues to flash amber notify Technical Service Malf...

Страница 37: ...tinuous pressing of the adjustment button The chair moves to memory positions by double clicking The foot control unit does not have any warning lights memory lights or operational status lights It is...

Страница 38: ...ng of the adjustment button Lowers the back of the exami nation chair Continuous pressing of the adjustment button Raises the foot supports of the examination chair only avail able on arco matic 300 M...

Страница 39: ...with the retaining bar as shown in Fig 45 The retaining bar must stand vertical to the back pad Now you can replace the paper roll etc WARNING The retaining bar is not designed to support a person s w...

Страница 40: ...Replacement Lift off the old seat pad Fig 46 Lifting off the old seat pad 1 Seat pad Put on the new seat pad The four pins on the back must fit into the opposite pin mounting hole Firmly press down t...

Страница 41: ...t Fold the back pad forward as shown in Fig 48 While firmly holding the head pad unscrew and remove the four attachment screws Hold on firmly to the head pad Remove the old head pad Mount the new head...

Страница 42: ...the locking wheel The rinsing basin is now locked at the set angle This angle is linked to the seat plate If the seat height is adjusted the inclination of the rinsing basin will also change RECOMMEND...

Страница 43: ...a later stage Remounting Unscrew two M3 Allen screws from the bracket mount see Fig 53 Insert the bracket mount in the insertion aperture on the other side see Fig 54 Fig 53 Cradle of hand control un...

Страница 44: ...and accessories that exceeds the lower of these two values Overloading can cause parts of the patient s body to suddenly fall off the table This could prove life threatening especially during treatme...

Страница 45: ...st be fastened to a side rail of the examination chair using the attach ment clamp 101 1670 0 Safe working load According to Fig 57 the safe working load for the G pel leg support is 25 kg when it is...

Страница 46: ...f the attachment clamp is not adequately fixed in place the inserted accessory may move unexpect edly and lead to hazardous situations The attachment clamp must be pushed the whole way onto the side r...

Страница 47: ...de from the opening Tighten the lower toggle screw each time you adjust the G pel leg support Adjusting the G pel leg support Loosen the toggle screw of the attachment clamp Change the inclination of...

Страница 48: ...le 2 Toggle screw of the cradle Fixing the lower leg in position Position the cradle under the leg CAUTION Supporting the leg the other way around by which the thigh is located in the strap section of...

Страница 49: ...t to help them get in or out of the chair Foot supports can be inserted in the mount for conical end pieces Foot supports can be adjusted with a control unit Safe working load see table in chapter App...

Страница 50: ...over the leg support stirrup Thread the zipper Pull the leatherette cover over the leg support stirrup and smooth it down Zip it closed Turn the leatherette cover until the zipper faced down Fig 68 M...

Страница 51: ...wer toggle screw WARNING Insufficiently secured accessories can come loose under load which many cause injuries or damage to property Prior to use ensure that all accessories have been properly secure...

Страница 52: ...n place 1 Cradle 2 Toggle screw of the cradle Fixing the lower leg in position Open the fastening strap Place the lower legs of the patient in the cradle Fit the fastening strap around the patient s l...

Страница 53: ...ace makers and other implants such as hearing aids Therefore do not use head cushions for patients with a pacemaker or other implants The head cushion is fixed to the head pad with a magnet It can be...

Страница 54: ...n they are transported on the examination and treatment chair Therefore never move the examination and treat ment chair when patients are sitting on it DANGER If the mains plug is not disconnected the...

Страница 55: ...nation and treatment chair fully Disconnect the mains plug Secure the power cord foot control and foot control cable Lift the pedal of the examination and treatment chair up with your foot The examina...

Страница 56: ...eft side of the foot cover WARNING The foot rest is not designed to be used as a support or lifting handle When subjected to such a load the foot rest will release from the examination chair Serious i...

Страница 57: ...Before use make sure that the insertable leg plate is completely inserted NOTE When the integrated leg plate is pulled out it may tilt up and sustain damage For this reason always pull the integrated...

Страница 58: ...The mount for the paper roll is enclosed on all sides and thus protected against dirt Fold the back pad forward as shown in Fig 48 Place the shaft of the paper roll into the shaft mount as shown in F...

Страница 59: ...insing basin Rinsing basin with convenient holder article number 101 0495 0 Manual tilt Automatically remains horizontal Can be locked at an angle using hand wheels Locks automatically Cannot be pulle...

Страница 60: ...justing the examination and treatment chair swivel the mounted colposcope to the side Remove the panel from the right or left side of the foot cover Insert the colposcope support in the mount as shown...

Страница 61: ...r no or only minimal electrical voltage Technical faults can however give rise to consider able voltages which on contact would be transmitted to people The potential equalisation protects patient use...

Страница 62: ...by wiping the device with a cloth soaked in the cleaning or disinfection fluid Products from SCHMITZ u S hne are delivered non sterile and cannot be sterilised Remove the pad from the supporting surfa...

Страница 63: ...ectious germs can be trans ferred to the bloodstream of the patient and third parties For this reason always replace damaged pads immediately NOTE The surface of the pad can easily be damaged For this...

Страница 64: ...r Carefully dry the surface afterwards Retaining Always store stainless steel products carefully so that they are accessible to air Always remove cleaning fluid residues prior to storage Always keep s...

Страница 65: ...n with the on off switch Socket fuses The sockets are protected with two fuses each Fig 86 Pos 1 The appropriate equipment fuses are also indicated on the examination and treatment chair below the soc...

Страница 66: ...d Accordingly no repair works may be performed while the examination and treatment chair is in use Replacement parts Replacement parts can be ordered from your author ised dealer or directly from Tech...

Страница 67: ...ings batteries and pads Under the General Terms and Conditions these wearing parts are not covered by the two year warranty period For these wearing parts SCHMITZ u S hne GmbH Co KG provides a one yea...

Страница 68: ...damage Yes Notify Technical Service Professionally replace the damaged components No No actions are required for this item 6 Is the examination and treatment chair wobbly Only if the examination and t...

Страница 69: ...ean this medical device prior to disposal Dispose of the components of this product e g metal parts electronic components foam e g pads PVC parts e g bellows hydraulic oil etc according to the applica...

Страница 70: ...n 2018 05 08 GBR ID no 2038823A Product identification Identification plate Fig 89 Identification plate e g arco matic 300 M Fig 90 Position of the identification plate 1 Identification plate Fig 91 I...

Страница 71: ...ied part Type B Weight of the examination and treat ment chair Protection class I Always use the product in accordance with the instructions for use Danger high voltage The capacity of both sockets is...

Страница 72: ...atients on the exami nation and treatment chair Only push a mobile examination and treatment chair when there is no one on it Packaging is recycled in Germany under the RESY system The product satisfi...

Страница 73: ...d width seat back 595 mm 680 mm 595 mm 680 mm Pad height 45 50 mm 45 50 mm Electromotive pelvic elevation minimum maximum height 550 mm 1 000 mm 550 mm 1 000 mm Electromotive pelvic elevation minimum...

Страница 74: ...9 A2 2013 see Glossary on page 82 IPX4 with closed safety cover IPX0 with open safety cover Protection class as per IEC 61140 2001 see Glos sary on page 82 I Suitability for use in oxygenated atmosphe...

Страница 75: ...on densing 20 95 at 30 C non con densing Air pressure 700 1 060 hPa Maximum permitted operating height 2 000 m above sea level Tab 19 Permissible ambient conditions Pads Surface Colour Lifespan Guaran...

Страница 76: ...Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A Connection dimensions Fig 92 Connection dimensions A Area for cable feedthrough for hardwiring B Right side C Left si...

Страница 77: ...s s i m e c i n o m r a H Voltage fluctuations flicker emissions IEC o t d e m r o f n o c 3 3 0 0 0 1 6 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material th...

Страница 78: ...an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz an...

Страница 79: ...Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A 79 EC Declaration of Conformity including accessories Fig 95 EC Declaration of Conformity Part 1...

Страница 80: ...80 Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A Fig 96 EC Declaration of Conformity Part 2...

Страница 81: ...Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A 81 Fig 97 EC Declaration of Conformity Part 3...

Страница 82: ...ot comply with the intended purpose will lead to exclusion of liability Applied part IEC 60601 1 2005 amend ment 2006 amend ment 2007 A1 2012 Part of an electrical medical device that necessarily come...

Страница 83: ...Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A 83...

Страница 84: ...e 7 Leatherette cover 50 Protective cover 7 50 Short variant 7 Foot support adjustment 11 Fuse electric 10 65 Replacement 65 Specification 65 74 G Glossary 82 G pel leg support Cradle 48 52 Plug in ve...

Страница 85: ...1 59 S Safety information 5 Safe working load 74 Definition 82 Seat height adjustment 11 Seat section 9 36 40 Protective cover see Protective cover Serial number 66 70 Service life Definition 82 Value...

Страница 86: ...86 Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A...

Страница 87: ...Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A 87...

Страница 88: ...88 Instructions for use arco matic 200 M 300 M Version 2018 05 08 GBR ID no 2038823A Contact information...

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