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230750-101  Rev. G 

33

Guidance & Manufacturer’s Declaration

Table 206

 – Recommended Separation Distances between  

Portable and Mobile RF Communications Equipment for ME Equipment and 

ME Systems that are NOT Life-supporting.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Recommended Separation Distances for between  

Portable and Mobile RF Communications Equipment and 

the Tono-Pen AVIA Vet.

The Tono-Pen AVIA Vet is intended for use in the electromagnetic environment in which radi-

ated RF disturbances are controlled. The customer or user of the Tono-Pen AVIA Vet can help 

prevent electromagnetic interference by maintaining a minimum distance between portable and 

mobile RF Communications Equipment and the Tono-Pen AVIA Vet as recommended below, 

according to the maximum output power of the communications equipment.

Max Output 

Power of 

Transmitter

(W)

Separation (m)

150kHz to 80 MHz 

Outside ISM Bands

d=(3.5/V1)(

P) 

Separation (m)

150kHz to 80 MHz  

In ISM Bands

d=(10/3)(3.5/V1)(

P) 

Separation (m)

80 to 800 MHz

d=(3.5/E1)(

P)

Separation (m)

800MHz to 

2.7GHz

d=(7/E1)(

P)

0.01

0.1166

0.1944

0.1166

0.2333

0.1

0.3689

0.6149

0.3689

0.7378

1

1.1666

1.9444

1.1666

2.3333

10

3.6893

6.1489

3.6893

7.3786

100

11.6666

19.4444

11.6666

23.3333

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can 

be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of 

the transmitter in watts (w) according to the transmitter manufacturer.

Note 1: 

  At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2:

  These guidelines may not apply in all situations.  Electromagnetic propagation is affected by absorption and reflection 

from structures, objects, and people.

Note 3:

  The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 

MHz to 2.7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause 

interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been 

incorporated into the formula used in calculating the recommended separation distance for transmitters in these 

frequency ranges.

Summary of Contents for Reichert Tono-Pen AVIA

Page 1: ...Tono Pen AVIA Vet Veterinary Tonometer User s Guide...

Page 2: ...notice Reichert Inc reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold ISO 13485 Certified R...

Page 3: ...12 Tono Pen AVIA Vet Tonometer Verification 13 Tono Pen AVIA Vet Tonometer Tones 15 Battery Installation and Replacement 16 Liquid Crystal Display User Interface 17 Tono Pen AVIA Vet Tonometer Prepar...

Page 4: ...CE WITH THE INSTRUCTIONS OUTLINED IN THIS USER S GUIDE THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY REICHERT TECHNOLOGIES...

Page 5: ...RY IN A POCKET OR CLOSE TO YOUR PERSON AS A BURN INJURY MAY RESULT WARNING THE BATTERY SHOULD ONLY BE REPLACED WITH THE BAT TERY SPECIFIED IN THIS MANUAL USE OF ANOTHER BATTERY MAY CAUSE FIRE OR AN EX...

Page 6: ...ECIFIED BY THE MANUFACTURER OTHERWISE DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD RESULT CAUTION AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT CAUTION DO NOT USE...

Page 7: ...ERENCE FROM OTHER DEVICES MAY AFFECT THIS INSTRUMENT IF INTERFERENCE IS PRESENT TURN OFF OTHER ELECTRONIC DEVICES OR REMOVE THEM FROM THE IM MEDIATE AREA WHILE OPERATING THIS INSTRUMENT CAUTION PORTAB...

Page 8: ...onic Equipment Compliance to Medical Device Directive 93 42 EEC Consult Instructions for Use Authorized Representative in European Community Fragile Contents in Shipping Container handle with care Do...

Page 9: ...guide to ensure optimum performance of your new instrument If used properly the Tono Pen AVIA Vet tonometer will provide you with fast accurate and reliable measurements for many years Properly traine...

Page 10: ...se are used to produce an averaged IOP measurement The measurement is displayed on the Liquid Crystal Displays LCDs A replaceable battery compartment houses the Tono Pen AVIA Vet POWERCEL battery pack...

Page 11: ...reen light on in Applanation Mode E Power Supply Tono Pen AVIA Vet POWERCEL battery pack F Activation Button Applanation Mode select button A B F C D E Figure 1 Key Features Accessories 230751 Tono Pe...

Page 12: ...the IOP and number of applanations collected After 6 applanations are collected the LCD will display the finaI OP along with a statistical confidence indicator After 25 seconds the device will automat...

Page 13: ...ointing down towards the floor 2 Press and hold the activation button for 5 seconds a beep will sound at one second intervals 3 At the end of the 5 second button hold the display will show dn 4 Keep t...

Page 14: ...ated if the display shows FAIL A single press of the Activation button will re start the verification test Note The Tono Pen AVIA Vet tonometer will remain in the Verification mode until it passes ver...

Page 15: ...eter generates two different tones A BEEP will sound when Power Up Mode fails Verification Mode fails Applanation Mode starts IOP testing is completed IOP values are out of range 99 At various points...

Page 16: ...attery that can be used with this device 1 Insert the Tono Pen AVIA Vet POWERCEL Battery into the base of Tono Pen AVIA Vet tonometer until fully seated The Battery is keyed for correct installation 2...

Page 17: ...tical when low symbol will flash User Interface Error Code LED Off Failed Self Test APPLANATION MODE USER INTERFACE SEQUENCE OF EVENTS User Interface Ready to Measure LED On 1 Beep Ready to Begin IOP...

Page 18: ...de LED Off Timeout not enough IOP values collected VERIFICATION MODE SEQUENCE OF EVENTS User Interface Begin Verification Mode Hold Tono Pen AVIA Vet tonometer with transducer down towards floor LED O...

Page 19: ...ks chips or other irregularities Do not use if these conditions are present 4 Slide an Ocu Film Tip Cover onto the Transducer Assembly until the ridge is seated taking care not to apply the tip cover...

Page 20: ...See Tono Pen AVIA VET Tonometer Verification section for details If the verification test resulted with the LCD displaying FAIL repeat the verification test or reference the troubleshooting section fo...

Page 21: ...i e ear nose distant object to minimize eye movement with eyes fully open 4 Hold the Tono Pen AVIA Vet tonometer as you would a pencil and position yourself to allow viewing of the Transducer Assembl...

Page 22: ...P measurement will appear above the mmHg field and the statistical confidence indicator will appear above the DATA field on the LCD Note If at least 2 applanations were read the avergae IOP will be di...

Page 23: ...rcury mm Hg along with a statistical confidence indicator A statistical confidence indicator of 95 means that the standard deviation of the valid measurements is 5 or less of the number shown The high...

Page 24: ...ow the canned air into the tip of the tonometer for approximately 3 seconds Note It is necessary to blow canned air directly into the tip so that the contaminants are pushed out 4 After cleaning the t...

Page 25: ...ilm tip cover installed to protect the tonometer tip from dirt and contaminants Suggested Cleaning Schedule Number of Patients per Week Number of Days Between Cleaning 10 30 100 15 300 7 600 1 Tono Pe...

Page 26: ...ilm tip cover for protection If the Tono Pen AVIA Vet tonometer is not to be used until a subsequent day the instrument and accessories should be placed in the storage case provided If the instrument...

Page 27: ...PPLANATION Section of this manual Old or improperly applied Ocu Film tip cover being used or non Reichert tip cover being used Replace Ocu Film tip cover Debris in tip Clean tip Mechanical or electron...

Page 28: ...ent Temperature range 10 to 60 C 14 to 140 F Relative Humidity range 10 to 80 non condensing Atmospheric Pressure range 50 kPa to 106 kPa 14 8 to 31 3 in Hg RANGE OF IOP MEASUREMENTS 1 99 mmHg ELECTRI...

Page 29: ...atory Classification Insulation Protection Internally Powered 6 V battery Ingress Protection IPX0 Applied Part Type BF Operation Mode Continuous Compliance The Tono pen AVIA Vet complies with IEC 6060...

Page 30: ...nvironment Emissions Test Compliance Electromagnetic Environment Guidance Radiated RF Emissions CISPR 11 Group 1 The Tono Pen AVIA Vet uses RF energy only for its internal function Therefore its RF em...

Page 31: ...s 1kV I O Lines 100kHz repetition frequency N A Mains power quality should be that of a typical residential commercial or hospital environment Surges IEC 61000 4 5 0 5kV 1kV Line to line 0 5kV 1kV 2kV...

Page 32: ...marked with the following symbol Radiated RF Electromagnetic Fields IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM at 1kHz E1 3 V m 80 MHz to 2 7 GHz 80 AM at 1kHz 10 V m 80 MHz to 2 7 GHz 80 AM at 1kHz...

Page 33: ...m 800MHz to 2 7GHz d 7 E1 P 0 01 0 1166 0 1944 0 1166 0 2333 0 1 0 3689 0 6149 0 3689 0 7378 1 1 1666 1 9444 1 1666 2 3333 10 3 6893 6 1489 3 6893 7 3786 100 11 6666 19 4444 11 6666 23 3333 For transm...

Page 34: ...t Level V m Compliance Level d 6 E P where d Minimum separation distance in meters E Immunity test level in V m P Maximum power in Watts W 385 380 390 TETRA 400 Pulse Modulation 18 Hz 1 8 0 3 27 27 V...

Page 35: ...ical Service Center or authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser s invoice This warranty is in lieu of all other warranties implied or ex...

Page 36: ...686 4555 Email reichert information ametek com www reichert com Authorized European Representative AMETEK GmbH Business Unit Reichert Carl von Linde Strasse 42 85716 Unterschleissheim Munich GERMANY E...

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