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SJÖBLOMS 015-2050 Manual Download Page 26

 

Combi-Gyn 

EU-Declaration of Conformity 

SJÖBLOMS 

+46 660 84251 

[email protected] 

5. EU-Declaration of Conformity 

EU DECLARATION OF CONFORMITY

 

according to MDD 2007/42/EC including Appendix

 

and according to CE-marking Directive 93/68/EEC 

Type of equipment:  Gynaecology and examination table 
Model:  

015-2050 

Product registration number: 13958

 

Model:  

016-2050 

Product registration number: 16437

 

 
Manufacturer

 

Sjöbloms Sjukvårdsutrustning AB

 

Myrängsvägen 8

 

S-891 50 ÖRNSKÖLDSVIK, SWEDEN 

Sjöbloms Sjukvårdsutrustning AB ensures that the above products are in 
accordance with the EU Council MDD 93/42/EEC, as well as the Swedish legislation 
in force (1993:584) on medical devices and the regulations issued by Medical 
Products Agency (LVFS 2003:11). 

 

 

 

 

 

Örnsköldsvik 2015-08-21 

 

Karl-Gunnar Sjöblom

 

Production Manager  
 

Summary of Contents for 015-2050

Page 1: ... COMBI GYN COMBINATION GYNAECOLOGY CHAIR EXAMINATION TABLE For models 015 2050 016 2050 NOTE The operator must read the user manual carefully BEFORE the product is used to avoid unnecessary risks to the patient and operator ...

Page 2: ...e paper roll 2 7 The function of the castors 2 8 Patient handles 2 9 Leg supports 2 10 The function of the siderail and leg support handles 2 11 Colposcope attachment 2 12 Proctology rectoscopy attachment assembly and operation 3 Maintenance Cleaning 3 1 Routine examinations 3 2 Cleaning 3 3 Lubrication scheme 3 4 Spare part list 3 5 Accessories list 3 6 Solutions for lubrication cleaning and disi...

Page 3: ...cts are modified Therefore we reserve against possible changes in the user manual WARRANTY Sjöbloms provides a two year warranty for material design and manufacturing defects provided the products are not subjected to tampering or excessive wear For the guarantee to apply the product must have been used in accordance with the user manual and the maintenance performed as specified IMPORTANT INFORMA...

Page 4: ...ption Combinated examination table and gynaecology chair with electrical control of height and Trendelenburg position seat section Chromed or white coated chassis of all welded steel tubes The backrest is controlled with a gas spring or an electric motor The cushions are stuffed with foamed plastic and upholstered with imitation leather The leg supports are available in two versions and are attach...

Page 5: ... be connected to a grounded 230V outlet The product is now ready for use 2 2 Height adjustment Hand control optional Foot control the foot control is standard Follow the arrows to adjust the couch up and down Note Ensure that no unauthorized persons are in the couch s working range as a pinch hazard exists when raising and lowering the product ...

Page 6: ...central lock by pressing down the arc Always keep the wheels locked during the examination 3 Lower the seat to its lowest position Help the patient to sit down in the middle of the seat cushion AND lean against the back support before you raise the chair 4 When the patient is getting up again it is important to grip the patient handles optional figure 4 and not the leg supports The leg supports ar...

Page 7: ...of the handles that are positioned on the side of the back rest Push the handle up and the gas spring helps to raise the back rest variably adjustable Lowering the backrest Push the handle in again and push the back rest down Note Ensure that no unauthorized persons are in the couch s working range as a pinch hazard exists when raising and lowering the product ...

Page 8: ...ir regulates the back rest or the seat section shock position Press the yellow button in the middle to switch between these functions The left pair adjusts the height of the gynecology chair Look at the symbols and follow the arrows to regulate the different Note Ensure that no unauthorized persons are in the couch s working range as a pinch hazard exists when raising and lowering the product ...

Page 9: ...Fasten the paper Tear off the used paper DONE A Unwind the black ball without fully removing it B Push the metal rod to the left C Pull the metal rod gently towards you it will then detach from the right hand side placement D Pull the rod fully from the left hand side placement and place a new paper roll on the holder E Mount the paper roll holder in reverse order DONE ...

Page 10: ...i Gyn Operation The function of the castors SJÖBLOMS 46 660 84251 info sjobloms com 2 7 The function of the castors The gynecology chair is equipped with central locking castors Free castors Braked castors ...

Page 11: ...handles can be adjusted along the accessory rail arrow and also be completely removed from the rail when necessary Standard Integral The Combi Gyn is available with two different types of leg supports Standard and Integral Both models can be adjusted variably in all directions up and down and forward and backward along the accessory rail ...

Page 12: ... turn more than once but you can not gain access because of the frame being in the way etc as the picture two pull the handle down applies to handle A or towards yourself applies to handle B then the tension mode is opened and you can turn back the handle without the achieved tension being released When you then release the handle it returns to the operational mode and you can repeat your hold 1 A...

Page 13: ...pe B 3 Place the colposcope attachment fixed bolt through the lift arm joint and the supplied loose bolt in the top pre drilled hole C 4 Tighten the bolt and nut The bolt in the top hole should be very tight The bottom nut should not be too tight so that the joints are not too heavy to move 5 Fit the colposcope on the attachment B 6 Insert the included top support in the tube end of the colposcope...

Page 14: ...om 2 12 Proctologi rerectoscopy attachment Guide in the supplied support legs of the procto recto attachment under the gynecology chair from the short side Get assistance from another person and turn the gynecology chair so that it rests on the side Attach using the enclosed screws ...

Page 15: ... kg Guide in the square tube in the direction of the arrow The attachment should look like this when it is fitted A A Lower the gynecology chair to its lowest position and remove the leg supports B Pull out the support legs C Adjust the feet so that both are resting solidly against the floor D For maximum stability the wheels should be directed as shown B C ...

Page 16: ...ke sure that the attachment has been locked in the installed position Place the knee supports at the desired height Ensure that both sides are fitted correctly before placing weight on the product The chrome plated patient handles can be adjusted along the accessory rail Place them so that the pillow end up close to the seat edge Place pillows on each patient handle as shown in the figure The prod...

Page 17: ...ng functions Castors and castor locking mechanisms Any damage to electrical cables Motor functions That joints and fittings are lubricated according to the lubrication chart 3 2 Cleaning Cleaning artificial leather Water and a mild soap solution is recommended Disinfection If the product needs to be disinfected use a diluted alcohol solution Too strong an alcohol solution can have a drying effect ...

Page 18: ...ubrication scheme Lubrication according to the schedule should be performed every 6 months or as needed 1 First lock the wheels 2 Enlist the help of another person and tip the couch on the side in order to lubricate the moving joints 3 The spray can in the pictures above indicates where to lubricate ...

Page 19: ...321630T3LPZ Castor directional locking 5 343100 0015004A Lift Motor Linak 6 312100 1110004C Backrest motor Linak 7 312100 1110004C Trendelenburg motor Linak 8 FS2001 Foot control two motors Linak 9 FS3001 Foot control three motors Linak 10 HB824500004 11 Hand control two motors Linak 11 HB834500003 11 Hand control three motors Linak 12 WN55 S95 M12x25 Locking handles large 13 WN55 S65 M8X16 Lockin...

Page 20: ...Combi Gyn Maintenance and cleaning Accessories SJÖBLOMS 46 660 84251 info sjobloms com 3 5 Accessories Neck cushion Patient handles White coated chassis Proctology rectoscopy attachment ...

Page 21: ...leaning and disinfecting SJÖBLOMS 46 660 84251 info sjobloms com 3 6 Solutions for lubrication cleaning and disinfecting R 1 Cleaning solution for artificial leather 5557001 Lubrication C068 Disinfection solution DAX Plus Cleaning solution Lubrication Disinfection ...

Page 22: ...Length 200 cm Length backrest 1 75 cm Length backrest 2 gyn position backrest 85 cm Width 70 cm Width seat 55 cm pad 53 cm Weight 88 kg without patient handles Height 57 95 cm Max height when seat up tilted 110 cm Max patient weight 165 kg Angle backrest 1 70o Angle backrest 2 gyn position backrest 53 o Angle Trendelenburg 7o ...

Page 23: ...s comply with EMC directives in accordance with standard EN 60601 1 2 At full load the motors can be used a maximum of 6 minutes hour The actuator manufacturer guarantees at least 10 000 cycles performance Controllers Max usage time 10 or 6 min h at continuous operation Complies with directives in accordance with standard EN 60601 1 ...

Page 24: ... gradually lose its stored energy It is therefore recommended that the batteries are recharged at least 8 hours before usage Battery life Battery life depends on several factors including the extent of discharging If the battery is discharged too extensively between charges the lifespan will be reduced Charging as often as possible is recommended The built in buzzer Charge the battery that is buil...

Page 25: ...s The CE label contains the date order number serial number and our contact information Max patient weight 165 kg Displays the adjustment of the back rest There is a label on each side of the chair Displays the adjustment of the seat section Trendelenburg position There is a label on each side of the chair ...

Page 26: ...5 2050 Product registration number 13958 Model 016 2050 Product registration number 16437 Manufacturer Sjöbloms Sjukvårdsutrustning AB Myrängsvägen 8 S 891 50 ÖRNSKÖLDSVIK SWEDEN Sjöbloms Sjukvårdsutrustning AB ensures that the above products are in accordance with the EU Council MDD 93 42 EEC as well as the Swedish legislation in force 1993 584 on medical devices and the regulations issued by Med...

Page 27: ...Contact details SJÖBLOMS 46 660 84251 info sjobloms com 6 CONTACT DETAILS SJÖBLOMS Myrängsvägen 8 891 50 Örnsköldsvik Sweden Tel 46 660 4842 51 Fax 46 660 180 00 E mail info sjobloms com Web page www sjobloms com ...

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