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68E3441 Rev. J

Specifications

PHYSICAL

DIMENSIONS

Size: 7 1/4” x 1” x 7/8”

(18.42 x 2.54 x 2.22 cm)

Weight: 2.1 oz. (59.4 g)

ENVIRONMENTAL REQUIREMENTS

Operational Environment

Ambient Temperature range: 15° to

35°C (59° to 95°F)

Relative Humidity range: 30 to 75%

Atmospheric Pressure range: 80 kPa to

106 kPa (23.6 to 31.3 in.Hg)

Transport and Storage Environment

Ambient 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)

ELECTRICAL

Input Voltage (Tono-Pen

OCU-CEL Batteries)
2 x 3V Lithium Manganese

Dioxide batteries

RANGE OF IOP MEASUREMENTS

Accuracy by manometric measurements

(95% Confidence)

Measurement

(mmHg)

Accuracy

(mmHg)

5-27

± 2.0

28-80

± 5.0

OCU-FILM + TIP COVER

Contains natural rubber latex

SOFTWARE REVISION

The software revision can be obtained by

contacting Reichert Technologies. The

serial number identifies the manufacture

date and will provide access to the

software version

-10°C

60°C

10%

80%

106 kPa

50 kPa

Содержание Tono-Pen XL

Страница 1: ...Tono Pen XL Tonometer User s Guide...

Страница 2: ...es meeting ISO 9001 13485 requirements No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical recording or otherwis...

Страница 3: ...stallation 12 Tono Pen XL Tonometer Preparation 13 Calibration Procedure 14 Instructions for Use 16 Performing IOP Measurements 16 Interpreting the LCD Screen 19 Cleaning Maintenance 20 Cleaning Instr...

Страница 4: ...LD BE USED IN STRICT ACCORDANCE 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 SPECIF...

Страница 5: ...ACTIONS QUESTION PATIENTS ABOUT ALLERGIES TO LATEX BEFORE MEASURING THEM WITH THE TONO PEN XL TONOMETER WARNING DO NOT CARRY THE TONO PEN XL OCU CEL BATTERIES IN A POCKET OR CLOSE TO YOUR PERSON AS A...

Страница 6: ...OF DAMAGE TO THE PRODUCT CAUTION DO NOT USE THE TONO PEN XL TONOMETER WITHOUT AN OCU FILM TIP COVER TO PREVENT DAMAGE TO THE TRANSDUCER ASSEMBLY CAUTION DO NOT TOUCH THE TRANSDUCER ASSEMBLY WITHOUT A...

Страница 7: ...FECT MEDICAL ELECTRICAL EQUIPMENT CAUTION ELECTROMAGNETIC INTERFERENCE FROM OTHER DEVICES MAY AFFECT THIS INSTRUMENT IF INTERFERENCE IS PRESENT TURN OFF OTHER ELECTRONIC DEVICES OR REMOVE THEM FROM TH...

Страница 8: ...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 not get Shippi...

Страница 9: ...w instrument If used properly the Tono Pen XL tonometer will provide you with fast accurate and reliable measurements for many years Properly trained eyecare professionals such as ophthal mologists op...

Страница 10: ...e anesthetized corneal surface is analyzed and stored for a statistical comparison process Each single valid IOP reading is digitally displayed on the liquid crystal display LCD When four valid readin...

Страница 11: ...ical confidence indicator and battery life status E Battery Compartment Where the batteries are located A B D C Figure 1 Parts Identification E Accessories 230570 Tono Pen OCU CEL Battery 230651 Ocu F...

Страница 12: ...tly inserting the stylus blade in the end slot After insertion slowly push the stylus forward and pry the cover up to remove Refer to Figure 2 CAUTION CHECK TO BE SURE THAT THE BATTERIES ARE INSTALLED...

Страница 13: ...are not to apply the tip cover too tightly or too loosely Make certain that the rubber is flat across the tip but not taut Refer to Figure 4 Figure 4 Ocu Film Tip Cover Placement OCU FILM Tip Cover CO...

Страница 14: ...ly The time between the first and second button press must be between 0 5 and 1 5 sec onds The Tono Pen will beep and display CAL 3 Wait approximately 15 seconds for the Tono Pen to beep The display w...

Страница 15: ...heck Replace the batteries and repeat the calibration check Note If CAL appears followed by a row of four dashes the unit did not go into calibration mode To correct this depress the but ton quicker t...

Страница 16: ...e ear nose distant object to minimize eye movement with eyes fully open 4 Hold the Tono Pen XL unit as you would a pencil and position your self to facilitate viewing of the probe tip and patient s c...

Страница 17: ...or calibration Then a sustained display of CAL will be seen which initiates the calibration sequence The calibration sequence must be successfully completed before further measurements can be accompli...

Страница 18: ...in sleep mode to conserve battery life If this occurs activate the TONO PEN XL by pressing the Operator s Button once 13 Replace the Ocu Film Tip Cover before using the Tono Pen XL unit on another pa...

Страница 19: ...instrument is activated Two rows of dashes followed by a beep indicates that the instrument is ready to take measurements CAL indicates that the instrument is in the process of calibration check or t...

Страница 20: ...air directly into the tip so that the contaminants are pushed out 4 After cleaning the tip with compressed air the Transducer Assembly will be cold Allow the Transducer Assembly to warm to room tempe...

Страница 21: ...ument for taking measurements may suggest that the batteries need replacing Note Replace the battery with P N 230570 Note Always replace both batteries Do not mix used and new batteries in the instrum...

Страница 22: ...in the storage case provided If the instrument is to be stored for an extended period remove the Tono Pen XL OCU CEL Batteries to avoid possible damage to the instrument due to battery leakage Disposa...

Страница 23: ...r being used Replace Ocu Film tip cover Low Tono Pen XL OCU CEL Battery capacity Replace Tono Pen XL OCU CEL Batteries Need to check calibration Perform calibration check procedure Debris in tip Clean...

Страница 24: ...ative Humidity range 10 to 80 non condensing Atmospheric Pressure range 50 kPa to 106 kPa 14 8 to 31 3 in Hg ELECTRICAL Input Voltage Tono Pen OCU CEL Batteries 2 x 3V Lithium Manganese Dioxide batter...

Страница 25: ...25 68E3441 Rev J Classifications Tono Pen XL Regulatory Classification Insulation Protection internally powered 6V battery Ingress Protection IPX0 Applied Part Type BF Mode of Operation Continuous...

Страница 26: ...used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 Class B The Tono Pen XL uses RF energy only for its inter nal function Therefor...

Страница 27: ...r quality should be that of a typical residential commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common N A Mains power quality should be that of a typical residential com...

Страница 28: ...istance in meters m Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels in each frequence range Interference may occur in...

Страница 29: ...mmended below according to the maximum output power of the communications equipment Max Output Power of Trans mitter W Separation m 150kHz to 80 MHz d 3 5 V1 Sqrt P Separation m 80 to 800 MHz d 3 5 E1...

Страница 30: ...ce 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 expressed Al...

Страница 31: ...31 68E3441 Rev J Notes...

Страница 32: ...55 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 Email i...

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