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4. Safety

4.1 Device Classification

CE Regulation 93/42 EEC: Class 2a
FDA: Class II

4.2 Warnings and cautions

 

Warning 

•  Do not use if the product is visibly damaged and periodically  
  inspect for signs of damage.

•  Do not use in the presence of flammable gases.

•  This product should not be immersed in fluids.

•  Do not fit mains power adapter into a damaged mains
  outlet socket.

•  Route power cords safely to eliminate risk of tripping or  

 

  damage to user.

 
•  This equipment should only be used by trained personnel.
  USA Federal law restricts this device to sale by or order of a   
 physician.

•  Only use approved Keeler power supply EP29-32777 or  

 

  instrument may malfunction.

 Caution

•  The product has been designed to function safely when at an  
  ambient temperature b10ºC and +35ºC.

•  Keep out of the reach of children.

•  To prevent condensation from forming, allow instrument to  
  come to room temperature before use.

•  Accuracy of IOP measurements is known to be affected by    
  variations and changes in corneal rigidity due to differences in 
  corneal thickness, intrinsic structural factors or corneal  

 

  refractive surgery. It is recommended that these factors are   
  considered during IOP measurement.

•  Keeler recommends the use of disposable hygienic chinrest    
  tissues on the chin rest before the patients place their chin
  on it.

•  This product should be used in a room with subdued lighting

•  Before using the Pulsair Desktop, press the 'Clear/Demo'  
  button for 1 second to dispel any minute particles of dust or  
  moisture which may have settled whilst the instrument was   
  not in use.

Summary of Contents for Pulsair Desktop

Page 1: ...Next Instructions for use Next...

Page 2: ...Taking the reading p18 11 Display examples p19 12 Printing p20 13 Replacing the printer paper p21 14 User menu options p22 15 Calibration maintenance and inspection p23 16 Specifications and electric...

Page 3: ...ut contacting the eye to aid in the screening and diagnosis of glaucoma It is an air puff Tonometer designed to accurately measure Intra Ocular Pressure IOP without making contact with the surface of...

Page 4: ...hank you for purchasing the Keeler Pulsair Desktop The product has been designed and manufactured to ensure that you will enjoy many years of trouble free and safe use Please follow the User Instructi...

Page 5: ...d conforms with the provisions noted within the 93 42 EEC Medical Device Directive Double insulated Type BF protections against shock Consult instructions for use Manufacturers name and address Keep d...

Page 6: ...e product has been designed to function safely when at an ambient temperature between 10 C and 35 C Keep out of the reach of children To prevent condensation from forming allow instrument to come to r...

Page 7: ...the external surface with a clean absorbent non shedding cloth dampened with a water detergent solution 2 detergent by volume or water isopropyl alcohol solution 70 IPA by volume Avoid optical surface...

Page 8: ...ext Home Back 8 6 Power supply assembly Set Plug Replace the blanking plate with the appropriate mains plug adapter if required or use IEC 60320 TYPE 7 connector not supplied IEC 60320 TYPE 7 connecto...

Page 9: ...lead and it s position in regard to the user and the patient Your Pulsair Desktop has four anti slip rubber feet ensure these are located well within the edge of your intended flat surface to ensure t...

Page 10: ...ry as a result of pulse respiratory and diurnal fluctuations In addition blinking squeezing fluid intake physical activity body position and even the direction of gaze can influence IOP Up to 4 readin...

Page 11: ...base unit and carefully screw the travelling lock clockwise until it is firmly located Note do not over tighten the travelling lock 2 Chinrest and chinrest height adjuster Rotate the chinrest adjuster...

Page 12: ...go through all the displays as per section 3 5 Motion sensitive wakeup mechanism The Pulsair Desktop is equipped with a motion sensor Upon moving the platform from left to right or vice versa the moti...

Page 13: ...und and an additional momentary indication on the display On pressing any other button or changing the eye the instrument resets to normal mode 9 USB transfer port This is used for transferring IOP da...

Page 14: ...align the instrument with the centre of the cornea prior to measurement Alignment is performed using the moving part of the Pulsair Desktop and the joystick for final alignment The Pulsair Desktop wi...

Page 15: ...instrument displays 25 and switched to hard puff The instrument shall stay in hard puff until two consecutive readings are less than 20mmHg c 50 This is shown when the reading is greater than 50mmHg i...

Page 16: ...strument To initialise the instrument ready for use 3 Remove the protective dust cap from the puff tube 4 Unscrew the transit lock if secured 5 Using the joystick bring the moving part of the Pulsair...

Page 17: ...mo button on the back of the patient s hand prior to taking a reading 4 Place disposable chinrest tissue on the chin rest Ask the patient to place their head on the chinrest 5 Adjust the chinrest heig...

Page 18: ...ross hairs alignment target 3 Using the joystick focus the cross hair alignment target until the correct focused position triggers the tonometer to fire automatically 4 Remain in the firing position u...

Page 19: ...s readings will automatically be excluded from the calculation When a pressure IOP of less than 5mmHg is detected the unit will display 5 READ AGAIN When a pressure IOP of greater than 25mmHg is detec...

Page 20: ...clear the print memory buffer USB data out Pressing the print button sends a flat file to the usb port in the following format R xx xx xx xx xx x L xx xx xx xx xx x This data may be able to be import...

Page 21: ...he lip on the top of the cover and gently pull towards you to open the printer cover Remove the empty paper roll 2 Place the new roll of paper into the paper holder making sure the free end is loose a...

Page 22: ...hange Options shown in table 4 Pressing the print menu button for 1 second moves you forward to the next Menu Option shown in table in this case the Desktop Level 5 Use the clear demo button to make y...

Page 23: ...Note Care should be taken not to damage the Puff Tube assembly during cleaning Caution Never use a dry cotton bud or tissue to clean the puff tube lens Never use a silicone impregnated cloth or tissu...

Page 24: ...nd calibration Keeler recommends an annual calibration for the Tonometer Do not modify this equipment without authorisation of the manufacturer This must be performed by an authorised Pulsair service...

Page 25: ...D infra red Complies with Electrical Safety Medical BS EN 60601 1 2006 Electromagnetic compatibility EN 60601 1 2 2007 Ophthalmic instruments fundamental requirements and test methods ISO 15004 1 2006...

Page 26: ...ined has had any exposure with the same instrument or an other ophthalmic instrument using an intense visible light source during the previous 24 hours This will apply particularly if the eye has been...

Page 27: ...ic emissions The Keeler Desktop is intended for use in the electromagnetic environment specified below The customer or user should assure that it is used in such an environment Emissions test Complian...

Page 28: ...000 4 5 1 kV line s to line s 1 kV line s for line to earth 1 kV line s to line s 1 kV line s for line to earth Mains power quality should be that of a typical commercial or hospital environment Volta...

Page 29: ...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 t...

Page 30: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 50 kHz to 80MHz d 1 2 p 80MHz to 800MHz d 1 2 p 800MHz to 2 5GHz d 2 3 p 0 01 0 12 0 12 0 23 0 1 0 38...

Page 31: ...of the foregoing warranty other than as provided above This warranty is exclusive and in lieu of all other warranties expressed or implied and all implied warranties of merchantability or fitness for...

Page 32: ...Environmental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at Product end of life that this Equipment is recycled and reused If...

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