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PLUSOPTIX A16 User Manual Download Page 19

 

Page 19/22 

 
 

Environmental conditions for operation and storage 

 
The plusoptiX 16 has been designed for the environment category "Environment in areas of 
domestic health care, except for vehicles and planes”. “plusoptiX 12” can be stored in its box. 
Do  not  put  the  box  near  heat  sources  (radiators,  fan  heaters,  etc.).  When  you  remove  the 
“plusoptiX 12” from its box for use, do not place it in the sunlight. 
 
 

Storage 

Temperature 

0 to +50°C 

Humidity 

10 to 80% non-condensing 

Operation 

Temperature 

+10 to +40°C 

Humidity 

20 to 80% non-condensing 

Max. Height 

Max. storage height 

<2000m 

(78,740’’) 

Max. operational height  <2000m 

(78,740’’) 

 
 

Dimensions and weight with and without the box 
 

plusoptiX S16          
without cradle  
without box 

 

Dimensions (HBD) 

 

165 x 140 x 248 mm (6½ x 5½ x 9¾ in) 

 

Weight 

 

0,7 kg (24.7 oz) 

plusoptiX S16         
without box  

 

Dimensions (HBD) 

 

190 x 155 x 265 mm (7½ x 6

⅛ x 10¾ in) 

 

Weight 

 

1,8 kg (52.9 oz) 

plusoptiX S16              
in the box 

 

Dimensions (HBD) 

 

270 x 420 x 210 mm (10

⅝ x 16½ x 8¼ in) 

 

Weight 

 

2,7 kg (93.5 oz) 

  
 

Manufacturer’s declaration about electromagnetic compatibility (EMC) 

 
The “plusoptiX 16” is intended for use in the electromagnetic environments listed below. 
Owners and holders of the “plusoptiX 16” are responsible for guaranteeing this environment.  

 

This product conforms to the EMC standard (IEC 60601 -1 -2). 

 

Note

: 

This equipment has been tested and found to comply with the limits for a Class B 
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to 
provide reasonable protection against harmful interference in a residential 
installation. This equipment generates, uses and can radiate radio frequency 
energy and, if not installed and used in accordance with the instructions, may 
cause harmful interference to radio communications. However, there is no 
guarantee that interference will not occur in a particular installation. If this 
equipment does cause harmful interference to radio or television reception, which 
can be determined by turning the equipment off and on, the user is encouraged to 
try to correct the interference by one or more of the following measures: 

 Reorient or relocate the receiving antenna 

 Increase the separation between the equipment and receiver 

 Connect the equipment into an outlet on a circuit different from that to which the 

   receiver is connected 

 Consult the dealer or an experienced radio/TV technician for help 

Summary of Contents for A16

Page 1: ...Vision Screener plusoptiX S16 User Manual Edition 10 31 2018 CAD Plusoptix GmbH Neumeyerstrasse 48 90411 Nürnberg Germany www plusoptix com Englisch ...

Page 2: ...res Figure 1 plusoptiX S16 in the box 6 Figure 2 View of the device s cradle 7 Figure 3 View of reverse side 8 Figure 4 Underside of the cradle with type plate 8 Figure 5 Setting the date and time 10 Figure 6 Switching between the home page help page and training videos 11 Figure 7 Measuring environment 12 Figure 8 Selecting the referral criteria 14 Figure 9 Home screen 14 Figure 10 Selection of t...

Page 3: ...he blue Warnings and tips are labelled with the Attention symbol The plusoptiX S16 fulfils the requirements of Medical Devices Directive 2007 47 EEC The plusoptiX S16 fulfils the requirements for a Type B applied part of IEC 60601 1 Only connect the plusoptiX S16 to the enclosed GSM36P12 P1J medical power supply The plusoptiX S16 can be stored and transported at a temperature between 0 C and 50 C ...

Page 4: ...ntment Note Preventative eye care with the plusoptiX S16 does not replace the eye examination carried out by an ophthalmologist An ophthalmologist remains the only one who can interpret the measurement values and establish a diagnosis The measurement values must not be used directly to prescribe glasses or contact lenses All children who are not already being treated by an ophthalmologist should u...

Page 5: ... informed that opening the plusoptiX S16 runs the risk of receiving an invisible electric shock The plusoptiX S16 loses its approval as a medical product when it is opened The operator is responsible for ensuring that the plusoptiX S16 is only opened by Plusoptix or a dealer authorised by Plusoptix for service or warranty cases Warning Use of accessories transducers and cables other than those spe...

Page 6: ...the contents of the box are complete The scope of delivery includes User manual for the plusoptiX S16 Vision Screener plusoptiX S16 GSM36P12 P1J medical power supply Power cord in the compartment under the device Optional accessories Wireless plusoptiX P12 label printer Self adhesive labels for the plusoptiX P12 If the delivery is incomplete please inform the seller of the plusoptiX S16 immediatel...

Page 7: ...re located behind the black protective screen with the smiley This smiley helps to keep the child s attention Attention If a child is not looking at the camera lens in the middle behind the hexagon during the measurement this can lead to a cancellation of the measurement or incorrect measured values of the visual symmetry Therefore do not use any other external fixation aids Note So that the prote...

Page 8: ... If you contact us regarding ongoing service or guarantee issues please make sure you always have the serial number of your plusoptiX S16 The serial number helps us to answer your question quickly 3 1 Connecting the plusoptiX S16 Connect the medical power supply to the power cord and then plug this in The LED on the power supply lights up green for confirmation Then connect the medical power suppl...

Page 9: ...s switched off This avoids the child being distracted by the picture on the external monitor during the measurement After the measurement replace the device on the cradle The screen of the plusoptiX S16 is now turned off again and the screen of the monitor shows an enlarged view of the results pages 3 4 Connecting the USB keyboard and mouse optional To enter data on the plusoptiX S16 it is necessa...

Page 10: ...highlighted 1 Using the orange arrows 2 set the right date and current time Confirm your entries with the green checkmark 3 The date time and display format can be changed at a later date in the settings 4 Zum Ausschalten drücken Sie kurz den Ein Aus Taster Der plusoptiX S16 fährt dann herunter More information about adjusting the settings and implementing a WLAN connection can be found in short m...

Page 11: ...erve only to aid visualisation of what is written in the user manual The header shows the status This includes among other things Date and time on the left side The navigation bar operates the device Among other things you can select the gear wheel 4 to access the settings the magnifier 5 to call up the database the GO button 6 to start a measurement If the GO button is flashing a measurement can ...

Page 12: ...asurement area can be found in short manual 2 on our homepage www plusoptix com under support 7 Performing measurements The plusoptiX S16 measures both eyes at the same time binocular in 0 5 seconds from a distance of one meter This means that even infants with a short attention span can be measured from the age of 5 months The simultaneous measurement of both eyes also facilitates a reliable comp...

Page 13: ...n room is unknown to the toddler The attention grabbing Warble sound in this unknown environment always arouses interest Avoid lengthy conversation with parents before the measurement Note If a child is not looking at the nose of the smiley face during the measurements this can cause a termination of the measurement or inaccurate measurement values of the gaze symmetry For this reason do not use a...

Page 14: ...ing Characteristic curve Select a group by touching the relevant button 2 and confirm by touching the green checkmark 3 7 3 Starting the measurement and adjusting the plusoptiX S16 After you have set the time and date the home page will be displayed every time you turn the plusoptiX S16 on again Figure 9 Home screen Select an age group by touching the appropriate age range see Figure 4 You must se...

Page 15: ...y touching the flashing GO button 1 or pressing the trigger you will start the camera and a warble sound will be heard You can now see the camera image on the screen Note A started measurement can be aborted by touching the screen Adjust the plusoptiX S16 so that both eyes can be seen on the screen and then slowly move the plusoptiX S16 towards the patient until the camera image can be seen in hig...

Page 16: ... as both pupils are surrounded by a green circle the line between the pupils turns green and another warble sound can be heard The plusoptiX S16 is now a metre away from the child and the measurement begins automatically A ping sound signalises the end of the measurement Results page camera image Results page measurement values Results page database only plusoptiX S16 7 4 Checking and documenting ...

Page 17: ... Transport ohne Gerätekarton Die Garantie erlischt auch wenn der plusoptiX S16 geöffnet worden ist Externe Geräte wie USB Speicher USB Tastatur und Maus sind nicht im Garantieumfang enthalten Serial number of the plusoptiX S16 The type plate with serial number S N 1601S xxx xxxx xxxx can be found on the bottom of the cradle If you contact us regarding ongoing service or guarantee issues please mak...

Page 18: ...IEC 60601 1 IR Plusoptix devices use infrared light with a wavelength of 870nm and a maximum intensity of 135mW sr WLAN interface standards Physical layer Supports 802 11 b and g standards Network architecture types Communication with cabled networks via access points Security WPA and WPA2 Transmit power 802 11b g 50 mW 17 dBm typically Frequency range 2 400 2 4897 GHz Operating channels 1 11 for ...

Page 19: ...se in the electromagnetic environments listed below Owners and holders of the plusoptiX 16 are responsible for guaranteeing this environment This product conforms to the EMC standard IEC 60601 1 2 Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection agains...

Page 20: ...tone If the floor is covered with a synthetic material the relative air humidity should not be less than 30 Electrical fast transient burst IEC 61000 4 4 2 kV 2 kV Only plugs that are usually available in domestic or clinical areas should be used Surge IEC 61000 4 5 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Only plugs that are usually available in domestic or clinical areas should be used Voltage dips sho...

Page 21: ...ting of the transmitter in watts W as indicated by the transmitter manufacturer and d is the recommended safe distance in metres m The field strength of fixed RF transmitters as determined by a site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked by the symbol shown Radio frequency electromagn fields IEC 61000 4 3 1...

Page 22: ... telecommunication devices transmitters and the plusoptiX S16 depending on the output power of the communication device as stated below Maximum output power of the transmitter in W Safety distance depending on the transmission frequency in meters 150 kHz 80MHz d 0 35 P 80 MHz 800MHz d 0 35 P 800 MHz 2 7GHz d 0 7 P 0 01 0 035 0 035 0 07 0 1 0 11 0 11 0 22 1 0 35 0 35 0 7 10 1 11 1 11 2 21 100 3 5 3...

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