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230750-101 Rev. G

Guidance & Manufacturer’s Declaration

Table 9 – Guidance and Manufacturer’s Declaration

Electromagnetic Immunity

Immunity to Proximity Fields from RF Wireless Communications Equipment

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The

Tono-Pen AVIA Vet

is intended for use in the electromagnetic environment as specified below

related to proximity fields from RF wireless communications equipment.

Immunity

Test

IEC 60601

Test Level

Compliance

Level

Electromag-

netic

Environment

- Guidance

Radiated

RF IEC

61000-

4-3

Test

Frequency

(MHz)

Band

(MHz)

Service

(MHz)

Modulation

Maxi-

mum

Pow-

(W)

Dis-

tance

(m)

Im-

munity

Test

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 V/m at

0,3 m

450

430-470

GMR 460,

FRS 460

FM ±5 kHz

deviation 1

kHs sine

0,3

28 V/m at

0,3 m

710

704-787

LTE Band

13, 17

Pulse

Modulation

217 Hz

0,2

0,3

9 V/m at

0,3 m

745
780

810

800-960

GSM

800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band

1, 3, 4, 25;

UMTS

Pulse

Modulation

18 Hz

0,3

28 V/m at

0,3 m

870

930

1720

1700-1990

GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE

Band 1, 3, 4,

25; UMTS

Pulse

Modulation

217 Hz

0,3

28 V/m at

0,3 m

1845

1970

2450

2400-2570

Bluetooth

WLAN,

802.11 b/g/n,

RFID 2450,

LTE Band 7

Pulse

Modulation

217 Hz

0,3

28 V/m at

0,3 m

5240

5100-5800

WLAN

802.11 a/n

Pulse

Modulation

217 Hz

0,2

0,3

9 V/m at

0,3 m

5500
5785

Содержание Reichert Tono-Pen AVIA

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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