User manual
Contents
1. SC ASS v 88S 2011 0068 v8 Operating table RiEye Mk2 Table of content 1 2 3 4 4 1 4 2 D 6 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 6 9 6 10 6 11 6 12 6 13 6 14 6 15 6 16 7 7 1 7 2 1 3 7 4 1 5 7 6 1 7 1 8 Introduction operating table RiEye Mk2 4 SLELO p ae denses a en 7 UNDPAC KI ane s nNr 7 Important Before USC ssssssssssssssssrssrsnrsnrrn ann Arn ARR A RAR ARR RAR A ERA RR RR RAA 8 Mounting Of packrest actuator ssmessusomesseevastiumesstorsmessi nmerbinmoe 8 Mounting of cushions sysoseesressrssrssessrrrrerrrn ren ren rrrr ran rankens rar rr rar enn nn nn 9 Product identification label sn 10 GO SU UC ie seis essa E EEEE EEEE 11 Picture and location Of components ccseeceseeeeeeeeeeeeeeeeeeenees 11 ATG OS OT S ee eee 12 Transport and parking of the table wheels and brakes 12 Setting the table in the right POSITIONING ccccecseeeeeeeeeeeaeeees 14 Hand control panel picture and description 14 Programmable user setting normal mode 15 Programmable user setting auto mode 16 Level 0 Anaesthesia position 16 Trendelenburg position cccceceeceeeeceeeeceeeeseeeeseeeeseeeeseueeseeesees 17 FOOCCONU ON OO E 17 Headrest lockable 21 Headrest WEIONUSSS ds en ni 22 Electrical adjustment option for weightless headrest 24 Headr2. MDD EU Directive 93 42 EEC for medical products Tested according to standard EN 60601 2 46 and SS EN 60601 1 39 Operating table RiEye Mk2 10 10 1 Technical data Specification Dimensions Back support Seat cushion Leg support Headrest Maximum width Maximum length Height Weight Maximum static load Safe working load Headrest Angle Height Length Back rest angle Leg rest angle Trendelenburg position Material Stand and frame Cushions Accessory rail Battery Battery charger Protection class Medical classification Working conditions Temperature Relative humidity Atmospheric pressure Length x Width 500 x 580 700 mm 430 x 580 700 mm 400 500 700 x 580 700 mm see section 1 for different models R5 R6 and R7 180 x 210 mm integral mould 750 mm foot print of chassis 1900 2000 2200 mm with patient in horizontal position with head in headrest 495 895 mm 95 kg excluding accessories 300 kg 3000N 300 kg 30 30 0 80 mm 100 350 mm minus when placed on backrest 80 vertical to 20 90 45 35 model R5 R6 R7 15 relative horizontal position of head Powder coated metal Standard or seamless design in different colours Stainless steel 24 V 10Ah Rechargeable lead acid charging time 4 hours 100 240V 450 mA Charge voltage 29 5V max 19W IP 65 vertically mounted IP 54 Class 1 10 C to 40 C 20 to 90 at 30 C 700
3. fluctuations flicker N A buildings used for domestic emissions IEC 61000 3 3 purposes 41 Operating table RiEye Mk2 Ad rini Guidance and manufacturer s declaration electromagnetic immunity RiEye Mk2 is intended to be used in the electromagnetic environment specified below The customer or the user must assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV Line to Line lt 5 Yo Ur gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Yo Ur gt 95 dip in r for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV Line to Line lt 5 Yo Ur gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Yo Ur gt 95 dip in r for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material then RH should be gt 30 Mains power qualit
4. for maximum patient comfort Never loosen the headrest mechanism B without supporting the patient s head with one hand under the headrest Lock A must be open when the backrest of the table is adjusted otherwise the patient may be harmed Depending on the patient s height a base setting of the headrest is made while the patient is in a sitting position backrest in upraise position according to the pictures below VI 7 Patient heigth up to 180cm Patient heigth over 180cm This default setting covers over 90 of all patient cases In cases where the patient has a special body constitution some additional adjustment may be necessary It is also important that the headrest is extracted a minimum of 60mm in order to take up the movement that is generally associated with the table backrest adjustment Minimum pull out length is indicated by a mark on the headrest rails For easy cleaning or if different types of headrests are used there is a quick release function to detach the complete headrest mechanism Make in such case sure that the locking screw A is tightened 23 fr Putloutto release Release of complete headrest 6 13 Electrical adjustment option for weightless headrest As an option fine adjustment of the angle of the weightless headrest can be made electrically by the hand control on the right joystick on the foot control moving it up or down To set the headrest in the middle po
5. side of the back rest 7 15 Protective cover for leg cushion The leg cushion can be equipped with an optional protective cover to facilitate cleaning and extend the life span of the cushion To mount the protective cover first detach the leg cushion and then pull over it over as shown in the picture below CM 7 e 2 4 TK S x tm S S N r 4 7 Mounting of protective cover for leg cushion 36 8 Cleaning and maintenance 8 1 Patient near surfaces Patient near surfaces need special attention regarding cleaning and maintenance and include Cushions Headrest Armrests and accessories Cover bow Soft headrest Anesthesia armrest IV pole foot rests and side rail 8 2 Periodic cleaning General cleaning of the table should be made at least once a week and exposed parts should be cleaned after each patient use Detergents Details Detergent information Cushions Headrest Stand Wheel If stronger detergents are used Mild soap rinse afterwards with water to Frame prevent drying and cracking Metal Plastic shell Painted surfaces Electronic parts such Use damp cloth as hand foot control joystick control box Note Do not flush with water and battery under pressure Use damp cloth if the charger is mounted vertically wet brush can be Battery charger used Note Do not flush with water under pressure 8 3 Disinfection Clean the table with disinf
6. surgery e Dental surgery If full anesthesia is used the table should be equipped with the optional extended leg rest and anesthesia armrest The table is only intended for indoor use and transport of patients on normal floor conditions The table may only be equipped with accessories and components that have been approved by Rini Ergoteknik AB Repairs or any other technical modifications of the table may only be performed by authorized personnel from Rini Ergoteknik AB The table should not be used by patients weighing more than 300kg The wheels must be secure and locked with the central break during operation Transport and parking of the table wheels and brakes The table has four large rotatable wheels where the left front wheel has a directional lock capability When space is limited or fine positioning side ways of the table needs to be done it is an advantage that all wheels can rotate To facilitate transport over longer distances the directional lock is available on the left front wheel This makes the table easy to steer Straight for instants during transport in corridors Direction lock will cause the table keeps a straight course and turn around the direction of the wheel locked All wheels have brakes which are centrally controlled by the foot pedals There are two identical ones on each side of the table that also control the directional lock BA rini AN Operating table RiEye Mk2 To break and lock
7. switched off automatically after 10 seconds idle time Never insert hand or other body in the mechanics of the table when it is in motion It can cause personal injury It is important that the foot control always is placed on the shelf when the table is not used or in transport mode The foot control should not be left on the floor or on the shelf retracted as is can be damaged and not function during patient treatment The foot control has the following label that defines to what standard the product has been tested and sets out some overall product data 19 Ad rini Operating table RiEye Mk2 Label Description Warning Risk is present Read accompanying text and information in the user guide Protective Safety against water penetration IPX6 means Class water proof but not washing machine proof Standard EN Product approval for medical products of this 60601 2 46 type 20 6 11 Headrest lockable The headrest is retractable and can be adjusted in height and angle by loosen two different locking mechanisms When these adjustments are made one hand must be placed under the headrest to support the patient s head B Angle and height adjustment A Length adjustment Angle and length adjustment of headrest To adjust the headrest first release the locking mechanism A to enable setting a suitable length of the headrest and then re lock the mechanism Secondly adjust the angle and height positi
8. the position of then table the foot pedal is pressed down The brake is released by moving the pedal in the opposite direction until the neutral position has been reached EL To set the directional lock first align the front left wheel strait and then press the foot pedal upwards gt _ a 7 Yr nee i To release the directional lock function move the pedal in the opposite direction one step down until the neutral position has been reached or two steps down to the brake mode Warning It is important that the wheels are kept locked during surgery Improper use may cause personal injury 13 6 4 Setting the table in the right positioning The headrest is manually adjusted in length height and angle with high precision and described in the section 6 11 Other parts of the table like height angel and combined position of various parts are electrically controlled This is done by the use of the hand control included as standard or in combination with the optional joy stick based foot control Great care has been given to make the hand control intuitive and easy to understand 6 5 Hand control panel picture and description On Off Memory position 1 6 Up left hand Down Ed im T Down left hand SF RER GG HH emm right hand Back rest Knee position position support Height of Trendelenburg Activate table Anaesthesia position Memory position Stor
9. to 1060 hPa 40 BA ini 10 2 Transportation and storage conditions Operating table RiEye Mk2 Transport condition Temperature 10 C to 50 C Relative humidity 20 to 90 at 30 C Atmospheric pressure 700 to 1060 hPa Storage condition Temperature 10 C to 50 C Relative humidity 20 to 90 at 30 C Atmospheric pressure 700 to 1060 hPa 10 3 Electromagnetic emission and immunity Medical electrical equipment is subject to special safety precautions regarding EMC requirements and must be installed and put into service in accordance to the following EMC information The aim is that the operating table not accidentally moves subjected to surrounding electromagnetic interference Guidance and manufacturer s declaration electromagnetic emissions RiEye Mk2 is intended to be used in the electromagnetic environment specified below The customer or the user must assure that it is used in such an environment Compliance Electromagnetic environment guidance RF emissions RiEye Mk2 uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to Cause any interference in nearby electronic equipment RF emissions Class B RiEye Mk2 is suitable for use in CISPR 11 all establishments including domestic establishments and Harmonic emissions N A those directly connected to the IEC 61000 3 2 public low voltage power supply network that supplies Voltage
10. with a drop of oil of oil Anaesthesia Lubricate the joints with a eee of oil armrest Collapsible side Lubricate the joints with a drop of oil rails Battery Batteries should be recharged at least once a month for continued capacity Most types of non corrosive lubricating oils can be used Optional accessories Spare parts and repairs Please contact Rini or your local Rini distributor for information regarding spare parts for your product The product should only be repaired by Rini or by Rini authorized service centre engineer Items under warranty must be sent to a by Rini authorized service centre Warning Unauthorized repairs and modifications may result in loss of function and void warranty 9 Safety The operating table should only be used as it is intended to as described in this guide Improper use and departure from the safety instructions can cause injury to personal or product This guide should always be available in conjunction with the operating table Necessary knowledge of the operating table is required before use This guide has to be read before equipment is put into service No other accessory than those mentioned in this guide may be used Please note warning signs on the product 9 1 Warning and other labels A Warning signs are used when there is a risk for patients staff or equipment 9 2 CE Deklaration of conformance Operating table 100 00101 00 01 follows
11. an be adjusted in height depth and sideways The wrist support is manufactured in stainless steel and is mounted on an adapter directly on the headrest mechanism that makes it easy to mount and remove when required Wrist support 33 Ad rini Operating table RiEye Mk2 7 10 Knee support Knee support comes in two versions that are practical to have available and provide more comfort for the patient Knee support round 150mm high and half round 200mm high 7 11 Special mattress for anesthesia Special mattresses with slow recovery materials can be placed on the operating table These are available as a whole pad or divided into sections These are useful during long operations and when the table in a horizontal or nearly horizontal position Special mattress 40mm whole pad 34 7 12 Belts Several types of belts are available if the patient needs to be fixed Belts 2100mm and 700mm 7 13 IV pool Easy to mount on a dedicated position either on the left or right hand side of the table Has twin hooks for infusion pumps and is easy to adjust in height IV pool can be mounted on right or left side 35 7 14 Drape support with and without air connection Both versions of the drape support are easy formable and keeps the drape over the patients head Air connection Drape support with air mounted on rail They can be attached on the standards rails either on the left or right
12. are done on the accessory rails on the back rest and can be adjusted in height Fixed driving handles are suitable if it is important that they are always ready to be used and it works with the space they occupy rn pA Fixed driving handles back rest 7 3 Driving handle back rest foldable Foldable driving handles facilitates transport of the table with our without patient Mounting of the handles are done on the accessory rails on the 29 Ad rini back rest Foldable driving handles are suitable if minimum space is desired Operating table RiEye Mk2 ky fee Fixed driving handles back rest 7 4 Attachment rails on seat In addition to the standard rails located at the backrest of the table there is an option to rails along the seat This is useful to increase the flexibility where to mount other accessories The rails are mounted with screws to the metal frame beneath the seat cushion Mini Attachment rail on seat available on right and left side 30 BA rini 7 5 Collapsible side rails Collapsible side rails increase the safety of the patient and are practical for the patient to hold on to These can be mounted on either left or right side of the table Operating table RiEye Mk2 Collapsible side rails available on right and left side 7 6 Anaesthesia armrest The anaesthesia armrest is comfortable for the patient with its soft cushion for pressure relief and can easily be adjusted with a
13. be set individually Special quick buttons are available for Trendelenburg and zero level positions as well as possibility to pre program six user settings RiEye Mk2 is based on a new base platform and is available in three models that can be equipped with most of the available accessories making it possible to customize the table for different mobile and stationary procedures Model R5 100 00105 00 Width 580mm and leg rest 400mm Suitable when physical space in the clinic is limited or the requirement is that the table should be possible to fold the table completely as a chair N d imi E Pini 2 D IfM O Model R5 with holder hand control and width extension Lei Model R6 100 00105 01 Width 580mm and leg rest 500mm This model offers a good compromise between mobility and patient comfort Ad rini Operating table RiEye Mk2 seunene san v Model R6 with holder hand control width extension driving handles backrest and foot control Model R7 100 00105 02 Width 580 or 700mm and Leg rest 680mm For longer treatments and anesthesia surgery this model is best suited Model R7 with electrical brake holder hand control width extension driving handles backrest foot control IV pole side rails and electrical headrest 2 Registration We at Rini are constantly working to improve our current products and develop new ones We always focus on the user and we ap
14. cled as car batteries If the battery is re placed with a patient on the table verify that the emergency stop is activated 21 Ad rini Operating table RiEye Mk2 l 7 1 Accessoaries to RiEye Mk2 some of the accessories ordered will come pre mounted on the table but can also be mounted afterwards These include Driving handle leg rest Attachment rails on the seat and Collapsible side rails Normally these stay fixed on the table some additional accessories are available so the table can be tailored to fit the preference of the surgeon and assisting personnel as well as the constitution of the patient or particular treatment These be attach either permanently or temporarily and include Anesthesia armrest Backrest extensions Wrist support Holder for hand control IV pool and Drape support with or without air Backrest Drape support extension with air width Example of accessories Driving handle leg rest recumbent patient In addition to the standard driving handles located at the backrest of the table there is an option to fit driving handles also near the leg rest This is useful if the transport of the patient is done mostly recumbent The driving handles are mounted with screws to the metal frame beneath the leg rest cushion 28 Driving handle leg rest 7 2 Driving handle back rest fixed Fixed driving handles facilitates transport of the table with our without patient Mounting of the handles
15. e On Off button On is activated by pressing the button with the padlock and is confirmed by a beep If no other button is activated in 10 seconds the system returns automatically to the Off position On mode is indicated by the adjacent LED indicator 6 6 ON mode is necessary to activate all other functions except for the Trendelenburg position which overrides the On Off function If the On Off button is pressed when the system is in the On mode then the Off mode is activated immediately When the system returns to the Off mode it will also reset the selected function key Buttons for primary adjustment of the table These buttons control the operating table functions Respective LED lights up when selected function is chosen Only one function can be selected at a time The function keys are used in conjunction with Up and Down buttons They have identical function of the left and right side of the hand control panel to fit left handed and right handed persons First select the desired function which is then guided Up or Down Table height Raise and lowers the complete table Back rest Change the angle of the back cushion Leg rest Change the angle of the leg rest Knee support This function elevates or lowers knee support Up Controls the upward direction after the selection function Down Controls the downward direction after the selection function Programmable user setting normal mode The butt
16. ecececeuceceuceceusessusessusessees 38 ON eee ee ns eN ie NESN 39 Warning and other labels cccccccceeecceeeeceseeceeeeseeeeeeeeseeesees 39 CE Deklaration of conformance ccccecccceeeeeeeeeeeeeeeesaeeeeeaeeess 39 TECNAICA CAG once tense ste E E E E E E E E E E E E E EA 40 DDC CHIC AUNOM RE 40 Transportation and storage conditions 4 Electromagnetic emission and immunity ccceceseeeeeeeeeeeeneees 41 PISO Sal ANG ECYC esseer EE ERE EE EREE SE 44 VV LE UE Li LA sni e E E 44 Ad rini 1 Introduction operating table RiEye Mk2 Operating table RiEye Mk2 Thank you for choosing Rini s operating table for microsurgery RiEye Mk2 with modern attractive design is developed functionally and ergonomically in close collaboration with a number of leading Swedish and international clinics The table has wide area of application in both stationary mode or in mobile roll in roll out procedures Great care has been put in the design of the table and its accessories to improve the freedom of movement for the surgeon and assisting personnel in the vicinity of the patients head The headrest is easy to adjust and has a unique ergonomic design that makes it comfortable for the patient and at the same time has high accessibility Thanks to smooth surfaces and smart seams as well as cushion that are easy to remove the table is easy to keep clean and hygienic RiEye Mk2 i
17. ectant or germicidal agents according to the manufacturer s instructions and follow the hospital s or clinic s protocol for cleaning of body fluids off the table s surface 37 Operating table RiEye Mk2 8 4 Recommended disinfection Detail Disinfectants Cushions and Virkon 1 concentration other parts of leatherette and most other Follow manufacturer s instructions disinfectants medium concerning the concentration without alcohol Moderate alcohol appears to dry and crack the seat and back material and should not be used Hand control and Noedischer Dekonta 1 3 concentration other electronics CCOTRADE RW 0 5 concentration and most other Follow manufacturer s instructions disinfectants Use damp cloth Other parts Same as above plus Follow the manufacturer s M alcohol Periform or instruction equivalent Maintenance and service Service Annual service of the table is recommended to maintain optimum performance of operational and maximize personal security Such services include e Safety check and replacement adjustment of moving mechanical parts and accessories if required e Check of cushions quality and damages to avoid bacteria traps e Check of electrical equipment batteries and battery charger Please contact your Rini distributor regarding service 38 Periodic maintenance Monthly Headrest Loosen the latch and lubricate the two joints with a Loosen the latch and lubricate the two joints
18. ers m Field strengths from fixed RF transmitters as determined by 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 G These guidelines may not apply in all situations as electromagnetic propagation is affected by absorption and reflected from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location used exceeds the applicable RF compliance level above the RiEye Mk2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 43 Operating table RiEye Mk2 RiEye Mk2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the RiEye Mk2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the RiE
19. est Rubens Pillow tunssssessaessrssrsssrsssanrrrrrrr ran rann enn rerna rann annan 25 Emergency Stop ie a an a ee 26 Charging and handling batteries monmnossssssresrrrssrresrrrsrrrrsrrrnr rr rr anna 26 Accessoaries to RIEye MK 2 ccccsseceseeeeseeeseeeseeenseonseeeneeeaeeeees 28 Driving handle leg rest recumbent patient ceeeeeeeeeeee ees 28 Driving handle back rest fixed 29 Driving handle back rest foldable cccccseccsseceeseeenseeenserenees 29 Attachment rails OMS AL sn rrn rens rr rna rann rn rr nn ran 30 C ll psible SId AIS he ee sn 31 PNAC SINC ola ANS eee sasroreostronSNnsreS 31 Backrest extension width and length 32 Holder for hand control 32 BA ini 7 9 7 10 7 11 7 12 7 13 7 14 7 15 8 8 1 8 2 8 3 8 4 9 9 1 9 2 10 10 1 10 2 10 3 10 4 11 Operating table RiEye Mk2 VVFISLSUDDORRS Sa a a a nue 33 Knee SUDDO a a ee 34 Special mattress for anesthesia ssmmsossessrresrrrerrrenrrrerrrrr rer r ren renar 34 EJ OM eee a ee ee ee 35 V TOO RP IE 35 Drape support with and without air connection 36 Protective cover for leg cushion cccceccceeeceeeeseeeseeeeeeeeneeenaees 36 Cleaning and MaiNteNaN Ce ccceseeecesseseesseseeseeseensesenseesensenses 37 FAN NEG SU AC CS wast en 37 Periodic cleaning ss 37 DISINTE CUON steers new ennaa Eaa AEE aaa ENNE 37 Maintenance and service ccccsecccsee
20. he electrical lifting mechanism Standard EN Product approval for medical products of this 60601 2 46 type 6 Getting started 6 1 Picture and location of components RiEye Mk2 is designd to allow for high mobility comfort for the patient and easy of use for medical professionals 4 ATTO oo v 888 y Main components of RiEye Mk2 Model R6 1 Headrest standard model 2 Hand control 3 Backrest width and length extension option 4 Drape support with air connection option 5 Side rails option 6 Leg rest show in picture is model R6 7 Detachable battery module 8 Front wheels left with directional lock capability 9 Emergency stop 10 Foot control option 11 Hand control on flexible holder option 12 Central break on all four wheels down ward position and control of directional lock on left wheel for transport upward position 13 Foldable driving handles backrest option See chapter 10 for more detailed technical specifications 11 gt gt Operating table RiEye Mk2 6 2 6 3 Crimi Areas of use The RiEye Mk2 operating table is designed for microsurgery and can be used either as a stationary unit in the operating room or used as a mobile unit according to the roll in roll out method The table gives high freedom of movement to surgeons and assistants around the patient s head and its intended areas of use include e Eye surgery e Ear nose and throat surgery e Esthetic facial
21. ne year from date of purchase For further information please see Rini s general condition of sale 44 Rini Ergoteknik AB Fagelsangsvagen 3B SE 186 42 Vallentuna Sweden Phone 46 8 594 77170 Fax 46 8 929 279 Email info rini se www rini se
22. o the desired position and then press the S button for approx 5 seconds that activates the storing capability confirmed by a beep Within 2 seconds select one of the buttons 1 6 to store the desired position and a successful programming is confirmed by a beep Level 0 Anaesthesia position Anaesthesia position is a pre programmed function that puts the table in horizontal position Table in pre programmed Level 0 position BA rini 6 9 Trendelenburg position In an acute patient situation the table can be tilted in the Trendelenburg position so that the patients head is lower than the rest of the body Operating table RiEye Mk2 droite a A un Table in pre programmed Trendelenburg position To quickly activate this function there is a dedicated button Trend for this that also overrides the unlock function with On Off button If this button is pressed the whole table is made flat with an angle of minus 15 degrees with the head in the lowest position handling this function so it is not activated by mistake It can cause i The Trendelenburg button overrides the On Off button Be careful personal injury 6 10 Foot control option The foot control is a factory mounted optional accessory that normally needs to be ordered with the table or upgrades in the factory The foot control gives additional control of some key adjustments normally to be used by the surgeon for fine tuning d
23. on B of the headrest so that the patient is comfortable and then re lock the mechanism When the table is used with a patient never loosen the headrest A mechanism without supporting the patient s head with one hand under the headrest For easy cleaning or ff different types normal or so t are to be used there is a quick release function to detach the complete headrest mechanism 21 Pull out to release Release of complete headrest 6 12 Headrest weightless A patent pending design has been developed to minimize the number of manual adjustments needed for medical staff during an operation cycle At the same time the patient will experience greater comfort compared to a conventional operating table The headrest is adjustable in length height and angle at the same time as the headrest is perceived as weightless It automatically adapts to the operation table different angular settings while the patient s head remains firmly fixed and height adjustment 22 gt gt Angle and height adjustment and lock for length Before the patient sits on the operating table check that the headrest can move freely in the longitudinal direction and the screw A is un locked Normally the screw A un locked and locked only if there are special needs that the length Is fixed Next adjust a base angle and height of the headrest bowl with the locking mechanism B The headrest should normally have a slightly raised angle
24. one hand grip It can be mounted on the left or right side on the rails on the backrest RELL HE Anaesthesia armrest 31 Operating table RiEye Mk2 1 7 7 8 Ad rini If backrest extensions are used first remove this on the side where the anaesthesia armrest should be mounted and then lock the armrest with the clamp Backrest extension width and length Used for pressure relief and comfort typically for large or tall patients Backrest width extension The width extension is identical for left and right side and is attached to the rails on the backrest The length extension can be used when the headrest is much extracted from the backrest and is mounted on top of the backrest to give comfort to shoulders Holder for hand control With the holder that is equipped with a rotatable top the hand control is always easy accessible for assisting personnel It makes it efficient to adjust the operating table and reduces the risk of the hand control to be damaged or activated by mistake The holder is formable for best ergonomics and is mounted on the chassis at optional location giving a fixed height of the hand control independent on the height of the table 32 Operating table RiEye Mk2 Flexible attachment of holder for hand control 7 9 Wrist support The wrist support is an accessory that is used to give pressure relief for the surgeon during operation It is built around a foldable bow that c
25. ons 1 6 handle pre programmed memory settings of the table Users can easily design up to six own chosen positions of the table for example Preparation Transport Surgery Recovery and store them A stored position Is retrieved by continuously pressing the button 1 6 until the stored position is reached How to store a desired position First adjust the table to the desired position using the button for primary adjustment of the table Then press the S button that activates the storing capability Within 2 seconds select one of the buttons 1 6 to store the desired position and a successful programming is confirmed by a beep If the selected button 1 6 already had a pre programmed position stored this setting will be replaced by the new one 6 6 8 Programmable user setting auto mode The basic functions are the same as describe in the previous section But instead of needing to press the selected stored position button continuously it is sufficient to keep it pressed for 1 second The table will then go to the stored position automatically If any button on the hand control or the foot control is activated during the automatic mode it will be stopped The auto mode is an extra option that is supplied on the users own risk as the medical directive for safety reasons require the function described in section 6 6 How to store a desired position in auto mode First adjust the table t
26. oval Make sure when mounting that the material between the cushions are place as shown in the pictures so it does gt ji v 3 not get stuck Mounting of cushions Before use for maximum safety of persons and equipment Read through this manual or make sure you have reveived the required training to handle this product Understand were the emergency stop is located and how to use it See chapter 6 12 in the manual Understand how Trendelenburg position is activated See chapter 6 9 in the manual gt gt gt 5 Product identification label The label is placed at the bottom of the table and states to what standard the product has been tested and sets out some overall product data mimi CE RINI ergoteknik ab Fagelsangsvagen 3B SE 186 42 Vallentuna Phone 46 8 594 771 70 Fax 46 8 92 92 79 Product Code 100 00105 01 Serial number 0001 00 Power supply 010 00601 00 External Charger 010 00235 00 Protective Class IP54 SWL 3000N s Mode of operation 10 Max Zmin 18min E Standard EN 60601 2 46 3 Made in Sweden Label Description Warning Risk is present Read accompanying text and information in the user guide RT Type B equipment with ground for protection against electric shock SWL Safe Work Load The table must not be loaded with more than the specified weight The value 3000N corresponds to 300 kg Mode of Average ratio between operating time and rest operation time of t
27. preciate hearing viewpoints and ideas that can move our products offerings forward So please do not hesitate to let us know what you think about our products Please register your Rini products to help us improve our service and support to you In addition you will receive the latest news from us on upgrades and new ergonomic product and solutions for your specific area Unpacking To ensure patient safety and the life span of the product it is important to observe the following instructions before use Please read this manual carefully and understand how to use the product before you start Before you unpack the product check the packaging e Make sure that the packaging has not been damaged during transport Report any damage immediately to the transport company and your local Rini representative Remove the packaging e Detach the top of the pallet and remove it e Take out any non installed accessories that are packed separately with the table e Remove the side sections of the transport pallet e Remove all the packing material such as plastic tape etc from the table Warning Do not use sharp tools when removing the packaging material This can cause damage e Make sure that the delivery includes all ordered parts Contact your Rini sales representative if you find any discrepancies e Lift the table carefully off the transport pallet and put it on the floor Warning Be careful when lifting the table off the pallet The
28. rnal charger unit delivered with the table shall be mounted vertically according to the picture below on a wall and connected to a normal 220 240V mains outlet A green light on the module indicates when the charger is active and ready to be used When the hand control is used a buzzer signal and blinking of the On Off LED can occur This indicates the battery needs to be recharge A fully loaded battery can handle approx 40 operations sessions with a patient weight of 75kg An empty battery is fully charged after approximately 4 hours and is thereafter automatically switched to maintenance charge so overcharging is not possible The battery is also designed so that it can be placed on a metal surface Battery charger without short circuiting 26 BA rini gt gt Operating table RiEye Mk2 To charge the battery remove it as shown above and put it into the external charger A yellow light will indicate that the battery is being charged and is turned off when the battery is fully charged Battery module Batteries older than 4 years should be replaced with new ones New batteries must be ordered from Rini or by a Rini approved distributor Make sure the new battery is fully charged before use Tip Take the habit of charging the battery at the end of the workday and order an extra battery that always is charged and stand by Battery dropped or subjected to hard impact must be checked Old batteries are recy
29. s battery powered and the settings are variably adjusted from sitting to horizontal position with the hand or optional foot control Customized positions can also easily be pre programmed The table is raised and lowered by two electrically driven telescopic columns The table is also equipped with electrically Trendelenburg feature that is activated by a button on the hand control panel The minimum height is below 500mm allowing for easy boarding and exit for the patient and the maximum height gives ensures good ergonomic working positions for the surgeon and assisting personnel Accessory rails are fitted with on each side of the back cushion enabling mounting of various optional accessories from Rini or third party The four large wheels with heavy duty ball bearings are all steerable for easy manoeuvring and the table can to reach the correct working position even when there is little space The chassis is painted with durable powder coating and important parts are covered with protective caps which make the table easy to clean The table has a new type of wheel suspension and stands steady even on uneven floors due to the unique adaptive chassis An ergonomic placed central break locks all four wheels simultaneous in operating mode If moved it can also move sideways thanks to wheels that easily rotate The hand control has an intuitive layout with easy choices in function where back leg and seat cushion as well as height can
30. sition and get maximum adjustment range press the button on the hand control and wait until the motor 7 hn Electrical angle adjustment of headrest 24 BA rini The electrical way of adjusting can be useful when the angle between the patient s head and the microscope needs to be fine tuned and the headrest as such is covered and sterile Operating table RiEye Mk2 Hand control layout for headrest Right joystick control headrest 6 14 Headrest Rubens Pillow The headrest Rubens Pillow is based on a stainless steel tray that is mounted on the standard headrest mechanism for length extraction The tray itself can be raised or lowered with a handle at the back of the headrest On the tray the Rubens Pillow is placed consisting of a soft and wide cushion for the patients head that also serves as a wrist support for the surgeon Headrest Rubens Pillow complete with cushion 25 Operating table RiEye Mk2 CINI 6 15 Emergency stop The table has an emergency stop which breaks the power supply to all the electronics If any position is being adjusted by the hand or foot control the table is put to a halt eranan Button for emergency stop Location of button for emergency stop To activate the emergency stop push the red button To deactivate the emergency stop turn the button in the direction of the arrows clockwise 6 16 Charging and handling batteries The exte
31. table is heavy and may cause injury Avoid bumping it as this can cause material damage Operating table RiEye Mk2 4 1 Ad rini Before using the product please check the following e The product has not been damaged in transport e All cables are connected as described in this manual Please contact your local Rini sales representative if you have any concerns Important Before use When you receive the table the base unit is normally already assembled and ready for use To reduce packing size and cost of shipping the only part that may need to be configured is the back rest and mounting of cushions lf accessories are separately included in the package they must be assembled as described in this manual or as directed by Rini or your local Rini representative All electrical connections are pre wired and ready to use Since the table is designed for battery power all you have to do Is check that the battery is charged and properly connected Also make sure that emergency stop is deactivated Mounting of backrest actuator If the actuator is disconnected in shipping then first fold the backrest in a position so that it is possible to mount the bolt with the included locking mechanism Attach clip on the inside Install shaft from the The clip is locked with a click Mounting of backrest actuator 4 2 Mounting of cushions The cushions have a quick locking mechanism that allows easy mounting and rem
32. uring operation These adjustments include raising and lowering the table as well as changing the angle of the back support Note that these are the same as available on the hand control Operating table RiEye Mk2 Joystick for cradle function and electrical headrest option Joystick for Activate Deactivate up down and backrest Foot control placed on designated shelf To use the foot control first push the green On Off button to activate the function and for safety reasons the button needs to be pressed for at least 0 5 seconds The active state is confirmed with a beep and the LEDs for the Table height and Back rest are lit on the hand control Foot control placed on retracted shelf gt gt gt If no joy stick movement is done during 10 seconds the system returns automatically to the Off position If green button is pressed when the system is in the On mode then the Off mode is activated immediately Le Foot control placed on the floor The foot control function should be tested before every new operation Activate Up Down Right Left and Deactivate To give flexibility and allow for a good ergonomic work positions the foot control can either be placed on the designated shelf on the chassis or on the shelf retraced approx 130mm or placed on the floor For safety reason the On Off button needs to be pressed for 0 5 seconds to be activate and is
33. y should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Equipment or System requires continued operation during power mains interruptions it is recommended that the Equipment or System be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level 42 Fr Operating table RiEye Mk2 Guidance and manufacturer s declaration electromagnetic immunity continuing Immunity test IEC 60601 test Compliance Electromagnetic environment level level guidance Portable and mobile RF communications equipment should be used no closer to any part including cables than the separation distance calculated from the equation applicable to the frequency of the transmitter Separation distance Conducted RF 3 Vrms d 12JP IEC 61000 4 6 150 kHz to 80 MHz poe ee d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80MHz to 2 5GHz d 2 3VP 800 MHz to 2 5 GHz P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in met
34. ye Mk2 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance acc to frequency of transmitter meters output power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz vance ae d 12VP d 2 3 P o oa 0 12 0 24 cs ees 0 38 0 73 212 2 8 O 038 38 B Transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer electrical equipment Warning Only use original spare parts and approved accessories A Warning Portable and mobile RF equipment can effect Medical A from Rini 10 4 Disposal and recycling RiEye Mk2 is mainly made from environmentally recyclable material The product consists of steel stainless steel aluminium PVC and other plastics Rini recommends that the material be sorted and recycled as much as possible in connection with the destruction of the product Electronic parts and cables Xx Electronic parts and cables shall be handled as electronic waste in accordance with local requirements Battery I vev The battery contains lead and must be discarded as car X batteries according to current environmental legislation an 11 Warranty The warranty is o
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