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Reprocessing

Instructions for use

Polaris 600

Overview of reprocessing procedures

Classification of medical devices

For reprocessing, medical devices and their

components are classified by their type of

application and the risk resulting from it:
– Non-critical medical devices: surfaces

accessible to users and patients, e.g., surfaces

of devices

– Critical medical devices: e.g., sterilizable

handles

Testing of procedures and agents

The cleaning, disinfection, and sterilization of

medical devices has been tested using the

following procedures and agents. At the time of

testing, the following procedures and agents

showed good material compatibility and

effectiveness:

Non-critical medical devices

Manual disinfection with simultaneous cleaning:
– Buraton

10F by Schülke & Mayr

Concentration: 1 %
Contact time: 30 minutes

– Dismozon

pur by BODE Chemie

Concentration: 1.5 %
Contact time: 15 minutes

Critical medical devices

Manual reprocessing

Manual cleaning:
– Neodisher

LM 2 by Dr. Weigert

Concentration: 2 %
Contact time: 10 minutes

Manual disinfection:
– Korsolex

extra by BODE Chemie

Concentration: 3 %
Contact time: 15 minutes

Machine reprocessing

Machine cleaning:
– Neodisher

MediClean forte by Dr. Weigert

– Neodisher

MediClean by Dr. Weigert

Machine disinfection (thermal):
– 93 °C (199.4 °F) for 10 minutes

Steam sterilization:
– 132 °C (270 °F) for 4 minutes

Non-critical medical devices

Manual cleaning and disinfection

Procedure:

Remove dirt immediately with a wipe soaked in

disinfectant.

Perform surface disinfection (scrub-and-wipe

disinfection).

After the contact time has elapsed, remove

disinfectant residues.

Wipe with a cloth moistened with water and

allow to dry.

Check all items for damage and external signs

of wear, such as cracking, embrittlement, or

pronounced hardening, and residual dirt.

Replace parts if necessary.

WARNING

Risk of electric shock or device malfunction

Liquid that enters into the device can cause

the device to malfunction or may damage the

device and endanger the patient.

Only scrub-and-wipe-disinfect device

surfaces and cables and make sure no liquids

penetrate into the device.

CAUTION

Risk of damage to the device

The device consists in part of materials that are

not resistant to certain components of surface

disinfectants.

It is essential to follow the instructions in this

chapter.

Содержание Polaris 600

Страница 1: ...Instructions for use Polaris 600 WARNING To properly use this medical device read and comply with these instructions for use Surgical light Polaris 600 ...

Страница 2: ...2 Instructions for use Polaris 600 This page has been left blank intentionally ...

Страница 3: ...nctions on the Polaris 600 and Polaris 100 200 light system 27 Sterilizable handle E 28 Wall mounted control panel option 29 Color assignment of the lights to the wall mounted control panel 30 Assembly and preparation 31 Checking for operational readiness before each use 31 Fitting the handle 32 Operation 35 Positioning a light 35 Positioning a light system 37 Positioning the MedView camera 38 Sta...

Страница 4: ...a 82 EMC declaration 82 Ambient conditions 84 Technical light data 84 Electrical data 86 Mechanical data 87 MedView camera 87 Polaris 600 remote control for MedView camera 88 Wireless video transmission 88 Combination with system components 90 Operating options 90 Classifications 90 List of accessories 92 List of accessories for Polaris light and MedView camera 92 Index 93 ...

Страница 5: ...r The following web page provides a list of the countries in which the trademarks are registered www draeger com trademarks 1 Consecutive numbers indicate steps of action with the numbering restarting with 1 for each new sequence of actions Bullet points indicate individual actions or dif ferent options for action Dashes indicate the listing of data options or objects A Letters in parentheses refe...

Страница 6: ...This target group includes healthcare professionals such as surgeons and OR nurses Reprocessing personnel This target group includes persons who are responsible for the reprocessing of medical devices WARNING A WARNING statement provides important information about a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION A CAUTION statement provides im...

Страница 7: ...chapter Overview Task Requirement Installation Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices Basic service activi ties inspection maintenance accord ing to the Mainte nance section Task Requirement Installation Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices Training in service...

Страница 8: ...se instructions for use The medical device must only be used for the purpose specified under Intended use see page 15 Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use WARNING Ri...

Страница 9: ... may occur which can result in personal injury and property damage Perform the service in accordance with the chapter Maintenance WARNING Risk due to incompatible accessories The use of incompatible accessories may adversely affect the functional integrity of the product Personal injury and property damage may occur as a consequence Use only compatible accessories The accessories that are compatib...

Страница 10: ... other electrical devices WARNING Risk due to electrostatic discharge Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations When touching the pins of connectors that carry the ESD warning symbol When establishing connections with these connectors To prevent malfunctions observe the following measures and ...

Страница 11: ...duction of thermal radiation into the operating field Obligation to report incidents Serious incidents involving this medical device must be reported to Dräger and the competent authorities WARNING Risk of device malfunction The light system can cause radio frequency interference Shielding of components or reorientation of the light system may be necessary CAUTION Risk of device failure Install th...

Страница 12: ... to drying out of the wound site If necessary the total irradiance must be adjusted by reducing the illuminance of individual lights see Setting the illuminance on page 42 WARNING Risk of personal injury and property damage Objects can fall down into the operating field Avoid collisions of the light heads or of parts of the arm system with other objects WARNING Risk of personal injury and property...

Страница 13: ...ce to pull the arm system beyond the stops WARNING Risk of property damage The light head may overheat during operation Do not cover the light head completely or partially WARNING Risk due to incompatible displays The displays used in combination with a Polaris light system must be approved for use in the patient environment according to IEC 60601 1 WARNING Risk of personal injury and property dam...

Страница 14: ... by regulation authorities The radio transmitter module of this device also complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation of the device Changes or modifications not expressly approved by Dräg...

Страница 15: ...ight fails As a single light the Polaris 600 light is classified as a small surgical light in accordance with IEC60601 2 41 Double or triple light combination The combination of 2 or more Polaris 600 lights as a surgical light system enables use in operating and treatment rooms and meets the requirements for a fail safe surgical light system Intended use of the Dräger disposable handle The Dräger ...

Страница 16: ...omogeneous light column with deep cavity illumination and minimal shadowing The adjustable color temperature good color reproduction and adjustable illuminance ensure optimum working conditions for demanding procedures within the operating field and the examination field The illuminance can be adjusted in the OR light mode Ambient light mode Endo light In the ambient light mode the surroundings ca...

Страница 17: ...s 600 17 Overview Overview Multimedia system with 2 Polaris 600 lights configuration example A Ceiling cover B IR receiver for Polaris 600 remote control for MedView camera 26588 H G N P M I I J L Q Q H A C F E E R O O K J D B S ...

Страница 18: ...ht spring arm I Gimbal mounting J Light control panel K Polaris 600 light L Polaris 600 light with MedView camera and radio transmitter M Display mount 24 inch to 32 inch with radio receiver N Display O Sterilizable handle E P Sterilizable handle Q Integrated handle R Wall mounted control panel S Polaris 600 remote control for MedView camera ...

Страница 19: ...t configuration example A Ceiling cover B Ceiling tube C Central axis D Light swivel arm E Light spring arm F Gimbal mounting G Light control panel H Sterilizable handle I Polaris 600 light J Polaris 100 light K Integrated handle L Wall mounted control panel 26890 A B C D D E E F F J H G K K G L I H ...

Страница 20: ... handle C Light control panel D Sterilizable handle E E Lens with LED F Bottom glass Polaris 600 light with sterilizable handle E and MedView camera A Gimbal mounting B Integrated handle C Light control panel D Sterilizable handle E E Lens with LED F Bottom glass G MedView camera 26592 A A B D E F C 26591 A A B D E F G C ...

Страница 21: ... B key Switch synchronization on off C key Reduce illuminance D key Increase illuminance E key Set color temperature F key Set light field diameter G key Switch ambient light Endo light on off For further information on controlling the lighting see Operation on page 35 26793 A B C D E F G ...

Страница 22: ...mote control for MedView camera A key MedView camera on standby B key Zoom out video image Wide C key Zoom in video image Tele D key Switch automatic exposure on off E key Reduce exposure manually F key Increase exposure manually G key Switch autofocus on off H key Focus on distant object manually I key Focus on near object manually J key Switch freeze frame on off 26679 A B C D E F G H I J ...

Страница 23: ...lluminance D key Set color temperature E key Set light field diameter F key Switch ambient light Endo light on off G key Switch synchronization on off Camera control area H key MedView camera on standby I key Zoom out video image Wide J key Zoom in video image Tele K key Switch automatic exposure on off L key Reduce exposure manually M key Increase exposure manually N key Switch autofocus on off O...

Страница 24: ...h enables the control of the Polaris 600 light with MedView camera via an OR server integrated OR system Information about the Polaris 600 control interface is available from Dräger Restriction when a Polaris 600 light is combined with Polaris 100 200 lights The functions of the Polaris 100 200 light cannot be controlled via the Polaris 600 control interface Abbreviations Abbreviation Explanation ...

Страница 25: ...ge is dam aged Use by YYYY MM DD Expiration date The product is a medical device CE conformity assessment pro cedure Quantity Storage temperature Relative humidity Ambient pressure Part number Lot number Serial number Revision index Protect from moisture 2 2 STERILIZE STERILE R NON STERILE REF LOT Take care when touching hot surfaces Warning Risk of hand injury WEEE marking Manufacturer Date of ma...

Страница 26: ...handle Handle adapter with sterile disposable sleeve e g manufac tured by Covidien Light field diameter X X Illuminance X X Color temperature Synchronization Ambient light Endo light MedView camera Light controlpanel Wall mounted control panel OR panel option Light field diameter X X X Illuminance X X X Color temperature X X X Synchronization X X X Ambient light Endo light X X X MedView camera X X...

Страница 27: ...0 Polaris 600 Polaris 100 200 Polaris 600 Light field diameter X X Illuminance X X Color temperature Synchronization Ambient light Endo light MedView camera Handle adapter with sterile dispos able sleeve e g manufactured by Covidien Light control panel Polaris 100 200 Polaris 600 Polaris 100 200 Polaris 600 Light field diameter X Illuminance X X Color temperature X Synchronization Ambient light En...

Страница 28: ...cal gloves are worn A wiping motion with one finger across the surface of the operating section at any location will adjust the illuminance see Setting illuminance on the sterilizable handle E on page 43 Double tapping with one finger on the surface of the operating section at any location will adjust the light field diameter see Setting illuminance on the sterilizable handle E on page 43 Polaris ...

Страница 29: ... operating signal will not be implemented Correct operation One finger at a time is touching the operating section Operating signal will not be implemented Several fingers are touching the operating section at the same time Wall mounted control panel option The wall mounted control panel can incorporate up to 3 light control panels Optionally it can include a camera control panel The keys on the w...

Страница 30: ...ls on the wall mounted control panel are identified by different colors on the right hand side These colors are also be found in the colored rings on the gimbal mounting of the associated light The uppermost light control panel on the wall mounted control panel and the associated color are always assigned to the uppermost light on the arm system 26564 ...

Страница 31: ...f the system is put into operation without first being checked Make sure that the system is checked for operational readiness WARNING Risk of property damage The light head may overheat during operation Do not cover the light head completely or partially WARNING Risk of infection Personnel and patient may become infected by a non sterile handle Use only sterile handles WARNING Risk of infection Th...

Страница 32: ...trol for MedView camera on page 58 Fitting the handle Fitting the sterilizable handle E Immediately before an operation fit the handle under sterile conditions as follows 1 Fit the handle A on the inner handle so that the markers B line up 2 Turn the handle A clockwise until the locking mechanism C engages audibly 3 Check that the handle is securely attached Turn the handle counterclockwise to do ...

Страница 33: ... solely for single use The disposable handle must not be reused reprocessed or sterilized The membrane on the disposable handle must not exhibit any cracks holes or other damage The inner handle must be free from damage To prevent soiling of the disposable handle do not unpack it until immediately before an operation Do not use the disposable handle if the packaging is damaged Do not use a knife t...

Страница 34: ...dle by the recessed grips and turn it counterclockwise To remove the disposable handle see Disassembly on page 67 36005 NOTE To facilitate fitting the disposable handle non sterile OR personnel may hold the light steady WARNING Risk of infection If the inner handle is not free from damage it may damage the disposable handle The inner handle must be free from damage A B 36006 WARNING Risk of patien...

Страница 35: ...from several lights overlap the heat input to the wound site may be unacceptably high This can lead to drying out of the wound site If necessary the total irradiance must be adjusted by reducing the illuminance of individual lights see Setting the illuminance on page 42 WARNING Risk of personal injury and property damage Do not place objects on the light heads or hang them on the arm system These ...

Страница 36: ...f the light head 1 Take hold of the integrated handle A and use it to position the light The light head is held at its new position Non sterile positioning of a light with a short gimbal mounting The short gimbal mounting has a shorter upper bow The light can be rotated by 330 around the horizontal axis at the central joint The rotational movement is limited in both directions by stops The non ste...

Страница 37: ...e operating field B is fully illuminated The second light C is positioned at the foot of the operating table The figure shows an example of how a combination of 3 lights and a display can be positioned to achieve suitable illumination of the operating field The main surgical light D is positioned laterally above the surgeon s shoulder to ensure that the operating field E is fully illuminated The s...

Страница 38: ...View camera A is permanently installed in the light head It is located in a segment next to the LED bulbs Position the light head so that the MedView camera has an open field of view B at all times The optimum distance between the MedView camera from the bottom glass of the light and the operating field is 90 cm to 130 cm 35 43 in to 51 18 in CAUTION Risk of personal injury The user s eyes can be ...

Страница 39: ...n The light is in operation The status LED A is not lit The light is in standby mode The status LED A is lit orange There is a light system fault see Fault Cause Remedy on page 60 Status LED for monitoring the power supply The status LED A for monitoring the power supply for the light system is located to the left of the key The status LED A is lit green The light is being supplied with mains powe...

Страница 40: ...e switch off procedure The light is in standby mode The status LED B is not lit If there is a light system fault the status LED B lights up orange see Fault Cause Remedy on page 60 Synchronization function Within a light system the Synchronization function can be activated at the light control panel of each Polaris 600 light When the Synchronization function is activated the selected Polaris 600 l...

Страница 41: ...ion function on a light When a Polaris 600 light in the light system is in the Ambient light mode the key on this light is deactivated The Synchronization function will not be activated when the key is pressed When all the Polaris 600 lights in the light system are in the Ambient light mode the key on the wall mounted control panel is also deactivated Switching the Synchronization function on The ...

Страница 42: ...olaris 600 light or from the wall mounted control panel Illuminance can always be set individually on the Polaris 100 200 light Setting the illuminance Setting illuminance on the light control panel and on the wall mounted control panel The description of this function applies to both the light control panel and the wall mounted control panel Only the light control panel is shown in the illustrati...

Страница 43: ...icator lights up with half brightness 3 When the key A is pressed again the LED C of the LED indicator lights up with full brightness At maximum illuminance all the LEDs of the LED indicator are lit with full brightness Setting illuminance on the sterilizable handle E A wiping motion with one finger across the surface of the operating section at any location will adjust the illuminance Each wiping...

Страница 44: ...e LED indicator B Increasing illuminance Make a wiping motion with one finger to the right A across the surface of the operating section The illuminance will be increased by one step The change in the illuminance is shown by the LED indicator B For further information on illuminance see Technical light data on page 84 NOTE The operating section of the sterilizable handle E must be dry to guarantee...

Страница 45: ...diation observe the following recommendations Set the lights to the minimum illuminance required for appropriate illumination of the operating field If a high level of illuminance is temporarily required it should be reduced again as quickly as possible If the maximum level of illuminance from one light is required the illuminance from the other lights must be reduced The light fields from the ind...

Страница 46: ...mum total irradi ance1 W m2 Recommended adjustment of the total irradi ance2 by reducing the illuminance Thermal radiation in the wound site after adjustment of the total irradiance Polaris 600 A 600 W m2 Acceptable Polaris 600 A Polaris 600 B 1200 W m2 Acceptable Polaris 200 A Polaris 200 B 1120 W m2 Acceptable Polaris 600 A Polaris 200 B 1160 W m2 Acceptable Polaris 600 A Polaris 100 B 1060 W m2...

Страница 47: ...laris 100 B Polaris 100 C 1520 W m2 Acceptable Polaris 600 A Polaris 200 B Polaris 100 C 1620 W m2 Acceptable 1 When all lights in the light combination are set to maximum illuminance 2 Maximum permissible total irradiance according to IEC 60601 2 41 corresponds to 1000 W m2 Light combina tion Maximum total irradi ance1 W m2 Recommended adjustment of the total irradi ance2 by reducing the illumina...

Страница 48: ...color temperature set for the light The color temperature when the light is switched on is the same as the color temperature set before the light was switched off 1 Press the key A The color temperature is increased 2 Press the key A again The color temperature is increased by a further step 3 The change in color temperature is shown by the LED indicator B 4 If the highest color temperature has be...

Страница 49: ...field diameter is increased by a further step 3 The change in the light field diameter is shown by the LED indicator B If the largest light field diameter has been reached pressing the key A again will reset the light field diameter to its smallest size For further information on the light field diameter see Technical light data on page 84 Setting the light field diameter on the sterilizable handl...

Страница 50: ... The light field diameter is increased by a further step 3 The change in the light field diameter is shown by the LED indicator B If the largest light field diameter has been reached double tapping again will reset the light field diameter to its smallest size For further information on the light field diameter see Technical light data on page 84 26614 26620 A B ...

Страница 51: ...wall mounted control panel is also deactivated Switching the ambient light mode on The description of this function applies to both the light control panel and the wall mounted control panel Only the light control panel is shown in the illustrations The light must be switched on before this function can be activated see Switching the light on and off on page 40 Press the key A for 1 5 seconds The ...

Страница 52: ...tatus LED B lights up After switch on the camera runs through an initialization procedure This procedure takes about 15 seconds The Automatic exposure and Autofocus functions are activated by default The camera can also be operated when the Polaris 600 light is in standby mode Switching the MedView camera off Press the key A The camera is in standby mode The status LED B is not lit The key does no...

Страница 53: ...shown by the LED indicator C The larger the image detail becomes the more LEDs light up The smaller the image detail becomes the fewer LEDs light up Automatic exposure function The Automatic exposure function is activated by default When the Manual exposure function is activated it is possible to switch back to the Automatic exposure function Press the key A The Automatic exposure function is acti...

Страница 54: ...The video image becomes lighter If the key is kept pressed the video image lightens continuously 4 The change in the exposure is shown by the LED indicator C The lighter the video image becomes the more LEDs light up The darker the video image becomes the fewer LEDs light up Optimum image illumination To achieve optimum image illumination the zoom function can be used to match the size of the imag...

Страница 55: ...LED B lights up Manual focus function With the Manual focus function focusing on an object is carried out manually When the Autofocus function is activated it is possible to switch to the Manual focus function 1 Press the key A or the key B The Manual focus function is activated 2 Press the key A The camera focuses on a more distant object 3 Press the key B The camera focuses on a closer object 26...

Страница 56: ...The status LED B lights up 2 Press the key A again Real time images are shown The status LED B is not lit Automatic white balance The white balance for the camera takes place automatically i e the camera adjusts itself automatically to the color temperature of the Polaris 600 light 26380 NOTE The MedView camera adjusts itself automatically to the color temperature selected for the Polaris 600 ligh...

Страница 57: ...tely see Replacing the battery in the Polaris 600 remote control for MedView camera on page 58 Status LED does not light up The battery is completely discharged or is defective To reestablish the function of the remote control the battery must be replaced immediately see Replacing the battery in the Polaris 600 remote control for MedView camera on page 58 Positioning the remote control 1 The remot...

Страница 58: ...t be stored in accordance with the manufacturer s specifications Batteries must not be disassembled opened or crushed Batteries must not be short circuited Batteries must not be exposed to either heat or fire Batteries must not be stored in direct sunlight CAUTION Risk of damage to the device Only 6LR61 6F22 or 1604D battery types may be used as otherwise the operation of the remote control may be...

Страница 59: ...lip on connector to the new battery observing the correct polarity E 6 Insert the new battery into the compartment 7 Close the cover 8 Close the housing flap 9 Perform a functional test see Checking for operational readiness before each use on page 31 10 Dispose of the old battery appropriately 11 Charge rechargeable batteries as required 27995 E ...

Страница 60: ...ponent The LEDs on the mains connection component are numbered and indicate the status of the light system 27270 20 21 22 23 24 25 30 31 32 Supply mains Emergency power Output voltage Initialize in progress Contact service Initialize system System number A System number B 0 8 7 65 4 3 1 9 2 0 876 5 4 3 1 9 2 A F E D C B ...

Страница 61: ... of the light are in working order Communication with the light is func tioning No remedial action necessary Flashing yellow See LEDs on the mains connection component signal combinations on page 62 23 System initializa tion Initialize in progress Off Light system is initialized No remedial action necessary Continuously yel low Light system is initializing during ini tialization do not press any k...

Страница 62: ...nection component is faulty Notify Dräger Service Pulsating yellow Processor of the mains connection component is working correctly No remedial action necessary No LED Status Cause Remedy No LED Status Cause Remedy 20 Mains power supply Sup ply mains Flashing yellow Internal fault in the mains connection component Input source is unknown Output voltage level is unknown Notify Dräger Service 21 Eme...

Страница 63: ...ction nec essary Continuously green Light is in operation No remedial action nec essary Continuously orange Electronics fault Notify DrägerService Status LED C Off Light system is not supplied with power Notify the in house technician or Dräger Service Continuously green Mains power is available No remedial action nec essary Continuously orange Mains power is interrupted light system is being supp...

Страница 64: ...e MedView camera is incorrectly set Remote control and MedView camera must be set to the same room address Notify DrägerService Remote control is not functioning status LED does not light up when key is pressed Battery is discharged Fit a new battery see Replacing the battery in the Polaris 600 remote control for MedView camera on page 58 Battery is defective Fit a new battery see Replacing the ba...

Страница 65: ...edView camera to standby mode Switch the MedView camera on again after a few seconds Connection between the radio transmitter and the radio receiver is interrupted Reestablish the connec tion 1 Push up the locking plate on the radio receiver housing dis play mount 2 Set the on off switch on the radio receiver to 0 3 Wait for approx 5 seconds 4 Set the on off switch on the radio receiver to I The c...

Страница 66: ...dure WARNING Risk of patient injury and of device malfunction Always observe the hygiene regulations of the hospital when handling devices which are contaminated with body fluids NOTE To avoid the risk of infections for hospital staff and patients always clean and disinfect the device after each use NOTE Do not use abrasive cleaners for cleaning NOTE Strictly follow the disinfectant manufacturer s...

Страница 67: ... Take hold of the handle section and press the locking mechanism A 2 Keep the locking mechanism pressed and turn the handle counterclockwise B until the markers C line up 3 Pull the handle D down to remove it Removing the sterilizable handle The handle is located on the bottom glass of the light and is removed from the inner handle by pulling 1 Take hold of the handle A 26638 A B 26647 28274 C D B...

Страница 68: ...d from the inner handle by pulling 1 Take hold of the disposable handle A 2 Pull the locking mechanism B on the disposable handle until the entire perforation is ripped open The locking mechanism is intended to ensure single use of the disposable handle and is unusable after it has been pulled 3 Hold the disposable handle by the recessed grips C and turn it counterclockwise D 4 Pull the disposable...

Страница 69: ...of the date of manufacture The number in the inner circle corresponds to the year of manufacture 15 2015 The arrow points to the month of manufacture 1 January The date of manufacture has no effect on the service life of the handle The handle can undergo up to 300 reprocessing cycles After that it must be disposed of 28426 NOTE Cleaning methods based on alkaline agents pH values 10 can increase ma...

Страница 70: ...xtra by BODE Chemie Concentration 3 Contact time 15 minutes Machine reprocessing Machine cleaning Neodisher MediClean forte by Dr Weigert Neodisher MediClean by Dr Weigert Machine disinfection thermal 93 C 199 4 F for 10 minutes Steam sterilization 132 C 270 F for 4 minutes Non critical medical devices Manual cleaning and disinfection Procedure 1 Remove dirt immediately with a wipe soaked in disin...

Страница 71: ... dry thoroughly Machine cleaning and disinfection Perform machine cleaning and disinfection using a washer disinfector in accordance with EN ISO 15883 preferably with a cart for anesthesia accessories and ventilation accessories Procedure 1 Observe instructions for use for the washer disinfector 2 Securely position items in the basket Make sure that all interior spaces and surfaces are completely ...

Страница 72: ...ting the sterilizable handle E on page 32 Fitting the sterilizable handle see Fitting the sterilizable handle on page 33 WARNING Risk of infection If the sterilizable handle exhibits cracks or deformation as a result of frequent sterilization the handle may fall into the operation field and or may not satisfy the infection prevention policy Make sure that the handle is not used in the event of suc...

Страница 73: ...repair WARNING Risk of electric shock There are conducting components under the housing cover Do not remove the housing cover Maintenance measures must be performed by the personnel responsible Dräger recommends DrägerService for repairs and complex maintenance tasks Term Definition Maintenance All measures inspection preventive maintenance repair intended to maintain and restore the functional co...

Страница 74: ...s for use Perform functional and visual inspection Check for deformations of the arm system and whether parts have become loose Check for paint damage and cracks in plastic parts Check whether all plastic parts are present and in the correct position Complete light and arm system Every 2 years Check electrical safety of the light system in accor dance with IEC 62353 Replace components if necessary...

Страница 75: ...e spring arm and readjust if necessary Check the arm system central axis swivel arm and spring arm for colli sion damage welding seams free of cracks Check for deformations of the arm system and whether parts have become loose Check for paint damage and cracks in plastic parts Check whether all plastic parts are present and in the correct position Perform functional and visual inspection Component...

Страница 76: ...ue of the components To maintain the function of all components this device must be inspected and serviced at the intervals specified by the manufacturer WARNING Risk of electric shock Disconnect all electrical connections from the power supplies before carrying out any work Component Interval Task Personnel responsible Locking segment of the spring arms Every 2 years Check the dimensions of the l...

Страница 77: ...just the stop upwards Pay attention to the distance to the ceiling Turn the set screw clockwise to adjust the stop downwards Adjusting the spring force The spring force of the spring arm must be adjusted if the light does not remain at the set height When adjusting the spring arm lift it approx 10o above the horizontal position Only in this position is it possible to turn the set screw If necessar...

Страница 78: ...oint using the set screw A Use an Allen key size 4 mm Turn the set screw clockwise to increase the braking force Turn the set screw counterclockwise to decrease the braking force Adjusting the braking force at the intermediate joint 1 Adjust the braking force of the joint using the set screw A Use an Allen key size 4 mm 2 Adjust the braking force of the joint using the set screw A Turn the set scr...

Страница 79: ...he locking segment must be replaced The locking segment must be greased before insertion 1 Remove the device from the spring arm 2 Check the dimensions of the locking segment minimum material thickness and minimum length and replace if necessary 3 Grease the locking segment and the gimbal mounting journal 4 Fit the device to the spring arm 27208 0LQLPXP OHQJWK PP 0LQLPXP PDWHULDO WKLFNQHVV PP 0LQL...

Страница 80: ... of the systems is met The inspection results must be documented in writing After acceptance the operational system is handed over to its owner along with the associated documentation A written record of the handover is filed for reference The users are instructed on the use of the system Polaris 600 remote control for MedView camera It may be necessary to change the room address if MedView camera...

Страница 81: ...of non rechargeable batteries Do not recharge the batteries The medical device battery contains pollutant substances Only applicable in the Federal Republic of Germany In accordance with the Battery Act BattG the end user is obliged to return batteries that contain pollutants to the place of purchase or dispose of them in public recycling centers The battery contained in the device therefore must ...

Страница 82: ...nsured that this device functions correctly in the desired arrangement before use The instructions for use for the other devices must be followed Electromagnetic environment This device may only be used in environments specified in section Environments of use on page 16 Emissions Compliance Radiated emis sions Class A Group 1 30 MHz to 1 GHz Conducted emis sions Class A Group 1 150 kHz to 30 MHz C...

Страница 83: ... bursts IEC 61000 4 4 Power cable 2 kV Longer signal input lines signal output lines 1 kV Impulse voltages surges IEC 61000 4 5 Voltage phase conductor phase conductor 1 kV Voltage phase conductor protective ground conduc tor 2 kV Magnetic fields at mains frequency IEC 61000 4 8 50 Hz 30 A m Voltage dips and short interruptions of the sup ply voltage IEC 61000 4 11 Voltage dips of 30 to 100 8 3 ms...

Страница 84: ...mperature 20 C to 60 C 4 F to 140 F Ambient pressure 700 hPa to 1060 hPa 10 2 psi to 15 4 psi Relative humidity 10 to 95 non condensing Technical light data Polaris 600 Polaris 600 with anti reflective bottom glass OR light mode Maximum central illuminance Ec1 160000 lx 120000 lx Central remaining illuminance of Ec with tube 100 100 with 1 mask 45 45 with 2 masks 45 45 with 1 mask and tube 45 45 w...

Страница 85: ...g the diameter of the light field 3 steps 190 mm 230 mm 280 mm 7 48 in 9 06 in 11 02 in 3 steps 240 mm 280 mm 320 mm 9 45 in 11 02 in 12 60 in Setting the color temperature 4 steps 3800 K 4400 K 5000 K 5600 K 4 steps 3800 K 4400 K 5000 K 5600 K Bulbs LEDs LEDs Number of LEDs 92 92 Number of LED modules 18 18 Service life of the LED bulbs 50000 hours 50000 hours Replacement of LED bulbs possible po...

Страница 86: ...Power supply with 24 V mains connection compo nent Mains power 24 V AC 50 Hz 60 Hz I max 7 9 A P max 190 VA Emergency power 24 V DC I max 5 8 A P max 140 W Output voltage 32 V DC I max 5 A P max 120 W Typical power consumption incl mains connection component at 100 V to 240 V AC 50 Hz 60 Hz Light at 100 illuminance 115 VA Light at 50 illuminance 70 VA Light in standby mode 35 VA Maximum connected ...

Страница 87: ...akes All details are subject to manufacturing tolerances MedView camera Camera retrofittable in light head Yes Video image transmission by means of radio standard WHDI Encrypted video transmission 128 bit AES Image sensor 1 2 8 CMOS Resolution Full HD 1920 x 1080 pixels Zoom 120x 10x optical 12x digital Objective width F 3 8 mm Wide to 38 mm Tele 1 8 to 3 4 Auto shutter Yes Minimum illuminance 100...

Страница 88: ...wer 18 mW Power supply 9 V from battery Size of battery 9 volt battery Battery type 6LR61 6F22 or 1604D Dimensions L x W x H 170 mm x 60 mm x 35 mm 6 69 in x 2 36 in x 1 38 in Weight 300 g 0 66 lb Holder for remote control Mounted on horizontal standard rail conforming to ISO 19054 All details are subject to manufacturing tolerances Wireless video transmission Range 10 m 393 70 in Modulation OFDM ...

Страница 89: ... x 130 mm x 83 mm 5 75 in x 5 12 in x 3 27 in with power plug 160 mm x 140 mm x 83 mm 6 30 in x 5 51 in x 3 27 in with radio receiver housing wall or ceiling Weight including power supply unit 250 g 0 55 lb Surface mounting possible Mounting in the display mount possible Ceiling mounting possible Radio transmitter Operating frequency European Union U NII band 5 GHz 5 180 GHz to 5 320 GHz and 5 500...

Страница 90: ...r Sterile Sterilizable handle Sterile Dräger disposable handle Sterile Disposable sleeve for handle adapter e g manufactured by Covidien Sterile Integrated handle at the light head Non sterile Light control panel on the gimbal mounting Non sterile Wall mounted control panel Non sterile Polaris 600 remote control for MedView camera Non sterile Classifications Protection class according to IEC 60601...

Страница 91: ...agnetic compatibility requirements and tests IEC 60364 7 710 VDE 0100 710 Low voltage electrical installations Part 710 Requirements for special installations or locations Medical locations European medical device classification for the Polaris 600 light system Class I UMDNS code for the Polaris 600 light system 12 282 European medical device classification for the Dräger Polaris disposable handle...

Страница 92: ...lizable handle set of 2 handles G92099 Dräger Polaris disposable handle1 optional Solo set of 120 packages each con taining 1 piece 1 The Dräger Polaris disposable handle is expected to be available in selected countries from the beginning of 2019 MP05701 Dräger Polaris disposable handle1 optional Duo set of 60 packages each contain ing 2 pieces MP05700 Handle adapter2 3 optional for disposable sl...

Страница 93: ...nce 42 Image illumination MedView camera 54 Inspection 73 Integrated handle 18 20 20 Intended use 15 L LED indicator 43 Light control area 23 Light control panel 20 20 21 Light field diameter 49 Light mode 16 List of accessories 92 M Mains power 39 Manual exposure 54 Manual focus 55 MedView camera 20 22 O Operating time Polaris 600 remote control 58 OR light 16 40 OR panel 24 P Patient safety 8 Po...

Страница 94: ... 39 Status LED light system 39 Sterilizable handle E 28 Switching the light off 40 Switching the light on 40 Switching the MedView camera off 52 Switching the MedView camera on 52 Symbols 25 T Target group 6 Total irradiance maximum 45 Troubleshooting 60 U Users 6 W Wall mounted control panel 18 23 White balance automatic 56 Z Zoom 53 ...

Страница 95: ...Instructions for use Polaris 600 95 This page has been left blank intentionally ...

Страница 96: ... for use are provided for customer information only and will only be updated or exchanged upon customer request Polaris 600 light system MD Dräger Polaris disposable handle MD Radio transmitter Manufacturer Drägerwerk AG Co KGaA Moislinger Allee 53 55 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com 9054591 GA 6932 155 en Drägerwerk AG Co KGaA Edition 7 2019 10 Edition ...

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