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Regulators IFU GB,FR,DE,NL Rev 03 

Page 9/44           

 12/02/2010 

 

XXXXX : sequence number 

Example: serial number 090300521 shows the regulator produced in March 2009, with 
sequence number 521.

 

GCE recommend that a product

 Periodic inspection

 is undertaken every year to check 

proper functionality of the regulator.  
GCE  recommend  that  after  5  years  of  operation  an 

Overall  maintenance

  function  is 

undertaken.  This  maintenance  consists  of  preventive  maintenance  operations, 
replacement  of  critical  components  and  re-testing  of  the product. 

Overall  maintenance

 

shall be carried out by GCE authorised person only. 

It should not be assumed that the Periodic Inspection and Overall Maintenance period 
recommended  by  GCE  cover  every  safety  procedure  or  practice  required  by  local 
regulations  or  statutory  requirements,  or  that  abnormal  or  unusual  circumstances  may 
not warrant or suggest further requirements or additional procedures. 

Maximum life time of the product is 10 years. 
At the end of the product’s life time, the product must be withdrawn from service. The 
owner  shall  put  in  place  a  relevant  procedure  to  ensure  the  product  cannot  be  used 
again.

 

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Repairs  activities  cover  the  replacement  of  the  following  damaged  or  missing 
components: 
 

  Inlet stem, 

  Flow-metering device, 

  Gauge, 

  Piston, 

  Pressure relief valve, 

  Quick coupler. 

 
The repairs shall be carried out by a GCE authorised person only. 

 

Any  product  sent back  to  a  GCE  authorised person for  maintenance  shall  be  properly 
packaged. The  purpose  of  the maintenance  has  to  be  clearly  specified  (repair,  overall 
maintenance). For product to be repaired a short description of fault and any reference 
to a claim number might be helpful.  
 
Some  repair  activities  concerning  to  the  replacement  of  the  damaged  or  missing 
components can be carried out by the owner of the product. The following parts can be 
replaced only: 

 

  Caps, 

  Flow knob and stickers, 

  Hose nipple (including o-ring), 

  Inlet stem o-ring. 

 

 

 Contact our customer service for appropriate component number 

 

 

All  labels  on  the equipment  must  be kept in  good,  legible  condition  by  the  owner 
and the user during the entire product life time. 

Summary of Contents for mediline MEDIREG II

Page 1: ...Regulators IFU GB FR DE NL Rev 03 Page 1 44 12 02 2010 MEDIREG II MEDISELECT II MEDICAL HIGH PRESSURE REGULATORS Document Nr 735 800 000 092 Date of issue 12 02 2010 Revision Nr 3 GB FR DE NL...

Page 2: ...thing helium carbon dioxide xenon specified mixtures of the gases listed air or nitrogen to power surgical tools Operations Transport Storage Keep the product and its associated equipments away from h...

Page 3: ...alve due to that the gas is going from high pressure to low pressure Joule Thompson effect Ensure that all equipment that is connected to the valve by at least a 2 metre hose According to Medical Devi...

Page 4: ...the pressure outlet can be used Pressure outlet I is fitted with a gas specific medical quick connector also called quick coupler The user can connect another piece of equipment to this outlet with a...

Page 5: ...nto the cylinder valve connector Turn the regulator into the correct position for use and tighten the nut by hand do not use tools Pin index connection Position the pin index over the cylinder valve w...

Page 6: ...sition Do not use excessive force Reset the flow control knob to on the ZERO position once the gas flow stops and the regulator is vented For regulators fitted with a pressure outlet ensure it is func...

Page 7: ...position Ensure that the accessory is connected to the flow outlet Slowly open the cylinder valve by turning the hand wheel in anticlockwise direction approx 1 to 1 turns Sudden opening of the cylind...

Page 8: ...hand wheel in a clockwise direction to the stop position Do not use excessive force Reset the flow control knob on the ZERO position when the gas venting has ceased valid for version with flow meterin...

Page 9: ...ears At the end of the product s life time the product must be withdrawn from service The owner shall put in place a relevant procedure to ensure the product cannot be used again 2 Repairs activities...

Page 10: ...pressure range P2 Outlet pressure P4 Max outlet pressure closing pressure Q Outlet flow Service or disposal date The serial number indicates the year the product has to undergo the overall maintenance...

Page 11: ...ent that it is modified serviced or repaired by personnel not employed or authorised by GCE or if the apparatus is used in a manner not conforming to its intended use GCE cannot be held responsible fo...

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