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Instruction Manual for the Delivery Table FREYA 3 

Page 2 

In  line  with  the  Council  Directive  93/42/EEC  of  14 June  1993  on  medical 

devices, this is a class I device. 

The  manufacturer  declares  that  this  device  is  compliant  with  the  essential 

requirements contained in Annex I to the directive and Act on medical devices. 

The  compliance  procedure  has  been  performed  acc.  to  Annex  VII  to  the 

directive. 

 

 

 

 
 
 

Manufacturer: 

FAMED 

ś

YWIEC Sp. z o.o. 

 Fabryczna 1 

34-300 

ś

ywiec 

Telephone numbers: 

Central unit 

(+48 33) 866 62 00 

Marketing Department 

(+48 33) 866 63 00 …02 

Export Department   

(+48 33) 866 62 50 …52 

Service Centre 

 

(+48 33) 866 63 25 

HOTLINE 

 

(+48 33) 866 63 75   

Fax:  

 

(+48 33) 475 58 90 

 
 
 
 
 
 
 
 
 

 

Summary of Contents for FREYA 3

Page 1: ...INSTRUCTION MANUAL Delivery table type LM 03 FREYA 3 Serial no Revision 2 00 Publication date 26 03 2015 FAMED YWIEC Sp z o o Annexes 2 3 4 Index of Spare Parts...

Page 2: ...e essential requirements contained in Annex I to the directive and Act on medical devices The compliance procedure has been performed acc to Annex VII to the directive Manufacturer FAMED YWIEC Sp z o...

Page 3: ...ranty null and void Before any repairs disconnect the device from the mains Safety notes Below is the warning Warning Follow the instructions for safe use This warning can be found on parts and mechan...

Page 4: ...ly exercise caution while adjusting the extended lying surface in relation to the permanent one as the distance between the permanent frame and the extended one is too small if the pressure knob is us...

Page 5: ...r underneath must be free of obstacles During the table movement avoid collisions Exercise caution while removing and mounting the permanent lying surface moulding Application of excessive force may l...

Page 6: ...8 ARMCHAIR POSITION OF THE DELIVERY TABLE CARDIAC CHAIR 18 3 9 QUICK LEVELLING OF THE THIGH AND BACKREST SECTIONS CPR FUNCTION 18 3 10 POSITION 0 18 3 11 EXTENDED LYING SURFACE FRAME POSITION ADJUSTME...

Page 7: ...used The user is obliged to ensure that the device is operated in compliance with its intended purpose and that it is operated under appropriate conditions in a manner pursuant to this instruction man...

Page 8: ...nel with the option of locking the respective electrical functions of the delivery table Control panel in the side rail Wired controller Foot controllers option 9 Backlight lamp from underneath the de...

Page 9: ...related to the structure technology and materials without compromising the technical utility parameters and safety of the device 1 7 Safety The device structure ensures safe operation and use provide...

Page 10: ...nvironment is described in which the medical device Delivery Table LM 03 should be operated The user should observe the guidelines and warnings included in the tables NOTE The use of accessories addit...

Page 11: ...ransport method and package type ensuring safe transport 2 2 Unpacking and first start up NOTE If the device is mounted by the service team of FAMED YWIEC Sp z o o then the user is exempt from perform...

Page 12: ...r the electronic table control system works performing all the functional table movements by use of all the available control elements foot controller and side panels Furthermore check whether the loc...

Page 13: ...elected functions so as to prevent the patient from their activation with the wired controller or the ones in the side rails The central control panel enables the control of the following delivery tab...

Page 14: ...at the same time inclination angle of the backrest and thigh sections AUTOCONTOUR Trendelenburg and reverse Trendelenburg angles The table controller without the central control panel or locking pane...

Page 15: ...with control panels on the outer side see Fig 2a whereas on the inner side with control panels see Fig 2b which enable the activation of the table functions by the patient and medical staff as describ...

Page 16: ...e Trendelenburg when you lower the lying surface to the min height or during the Trendelenburg position marking compliant with pt 8 2 3 3 Backrest section angular position adjustment with the CPR func...

Page 17: ...central panel are marked with the symbol Angular couch position can be changed only by medical personnel The Trendelenburg position is a rescue position NOTE Do not lay any objects on the plastic base...

Page 18: ...e patient s head and push the backrest section down So as to level the thigh section pull the lever under the shank section and push the thigh section down 3 10 Position 0 The position 0 of the delive...

Page 19: ...e between the mounting element of the hand holder and the side rail Failure to observe the above note may at the extreme angles lead to crushing the patient s operator s fingers or to damaging the del...

Page 20: ...r underneath must be free of obstacles During the table movement avoid collisions Do not roll the delivery table across electrical cables 3 15 Use of the side rails Fig 4 The side rails fig 4 are atta...

Page 21: ...ht be damaged Application of excessive force might result in damaging the mouldings 3 17 Infusion rod The infusion rod is embedded in bushings located in the permanent lying surface frame near the hea...

Page 22: ...ually with the agents recommended in annex 2 to this instruction manual NOTE Use foil underlays for spots exposed to preparations applied during various procedures The contact with preparations for di...

Page 23: ...Instruction Manual for the Delivery Table FREYA 3 Page 23 4 Utility parameters The schematic figure below presents the most important utility functions of the delivery table and their marking...

Page 24: ...tion contained herein do not operate it Consult with the manufacturer supplier dealer Using the defective device may lead to damage sustained by the user for which the manufacturer assumes no liabilit...

Page 25: ...rotection NOTE The device contains products which may pose a threat to the environment gel battery type EP 1 2 12 2 pcs Rules of conduct as regards worn products that may pose a threat to the environm...

Page 26: ...should be settled acc to pt 6 6 Troubleshooting So as to ensure safe and reliable functioning within the device lifetime the user shall perform inspections as regards the compliance with standard IEC...

Page 27: ...pply cable disconnected controller defective control system or actuator connect the controller notify an authorised service centre seat section angle adjustment actuator will not work disconnected pow...

Page 28: ...ng features The user is to ensure that the medical device Delivery Table LM 03 is used in this type of environment Resistance IEC 60601 1 2 Test level Resistance level Explanations and guidelines Elec...

Page 29: ...a should be lower than the column resistance level within the entire frequency range b There might be interference in the medical device functioning if the column is being used in the vicinity of equ...

Page 30: ...ective identification plate areas 1 Logo symbol manufacturer production date manufacturer name and address 2 Device symbol 3 General marking CE marking Warning Follow the instructions for safe use Not...

Page 31: ...t 215 kg 39 st 250 kg 6 Maximum load of the extended lying surface frame 27 st 170 kg 7 Note For cleaning washing and disinfecting do not use agents which contain active oxygen or chlorine 8 Infusion...

Page 32: ...st inclination adjustment pedal option 18 Seat inclination adjustment pedal option 19 Warning Follow the instructions for safe use 20 Follow the instructions Note The manufacturer reserves the right t...

Page 33: ...00 3 Famed ywiec Sp z o o 6 Extension cover 1 C220920000003 B00 3 Famed ywiec Sp z o o 7 Lying surface mattress 1 C220920100000 A00 3 Famed ywiec Sp z o o 8 Extension mattress 1 C220920110000 3 Famed...

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