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Instruction for use

9 Technical specifications

AT 030

9.1 Compliance

319300-9120-000-GA-GB-240320

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9 Technical specifications

9.1 Compliance

If modifications not authorized by the manufacturer are made to
the device, this declaration ceases to be valid.

9.1.1 Directives with which the device is compliant

The device complies with the 93/42/EEC Medical devices directive
(MDD)

Device class in accordance with the MDD: I (with measuring
function)

The device is marked with

9.1.2 Classification of the device

UMDNS No.: 16-809

The AT 030 applanation tonometer conforms to the ISO 8612:2009
standard.

9.2 Device data

Value

Measuring prism

2 prisms for image splitting

Diameter of applanation
surface

3.06 mm

Measuring force range of
precision spring tonometer

0 mN to 78.4 mN

Scale reading

0.98 mN

Measurement accuracy

according to ISO 8612:2009
9.81 ± 0.49 mN
19.61 ± 0.49 mN
29.42 ± 0.49 mN
39.23 ± 0.59 mN
49.03 ± 0.74 mN
58.84 ± 0.88 mN
68.65 ± 1.03 mN
78.45 ± 1.18 mN

Содержание AT 030

Страница 1: ...AT 030 Applanation tonometer Documentation set...

Страница 3: ...00 Inhalt0 GB 240320 Contents Instruction for use AT 030 Applanation tonometer 319300 9120 000 GA GB 240320 Instructions for use and disinfection of tonometer measuring prisms 319300 9231 000 AddGA01...

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Страница 5: ...319300 9120 000 Inhalt1 GB Contents Instruction for use AT 030 Applanation tonometer 319300 9120 000 GA GB 240320 1...

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Страница 7: ...AT 030 Applanation tonometer Instruction for use...

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Страница 9: ...s 8 2 4 Measures and duties of the operator 8 2 5 Maintenance measures 9 3 Description of the device 11 3 1 Package check list 11 3 2 Device marking 11 3 3 Structure of the device 12 3 4 Functional de...

Страница 10: ...ological check 33 7 2 Adjusting the swivel mounted tonometer holder with square mounting interface version a 34 7 3 Adjusting the swivel mounted tonometer holder with round mounting interface version...

Страница 11: ...Correct operation of the device is imperative for its safe and successful functioning u Read these instructions for use before setting up and using the device the first time u Keep the instructions fo...

Страница 12: ...nces u This is a measure with which hazards can be prevented CAUTION This is warning information about hazards that can cause injuries if not avoided The warning message names the possible consequence...

Страница 13: ...he intraocular pressure of a seated patient 2 3 Responsibilities and duties of the operator Operating personnel The device may only be operated by instructed and trained personnel u Ensure that the op...

Страница 14: ...ZEISS representative 5 2 3 1 Messages to manufacturer and authorities If a serious incident occurs in connection with this medical device affecting the operator or another person the operator or perso...

Страница 15: ...t the device over long distances e g move return for repair etc only in original packaging or special return packaging u Contact your dealer or ZEISS Service 2 5 Maintenance measures Maintenance proce...

Страница 16: ...Empty page for your notes...

Страница 17: ...the AT 030 applanation tonometer includes the following components AT 030 applanation tonometer Box with measuring prisms and test weights Documentation set 3 2 Device marking Labels Explanation AT 03...

Страница 18: ...e 1 Control elements of the AT 030 applanation tonometer and the swivel mounted fixed tonometer holder 1 AT 030 applanation tonometer 2 Rotary knob of graduated drum 3 Knurled screw 4 Base plate of fi...

Страница 19: ...or ZEISS slit lamps according to the principle applied by Professor Goldmann The measuring device containing a measuring prism with built in optical doubling system is mounted on the slit lamp using a...

Страница 20: ...Empty page for your notes...

Страница 21: ...een specifically developed for the use of the AT 030 with ZEISS slit lamps and can be purchased separately The tonometer holder permits observation of the measuring prism through the left or right eye...

Страница 22: ...mounted tonometer holder using the size 3 screw driver supplied 3 Attach the device to the base plate of the tonometer holder and fix it by means of the knurled screw 4 Ensure that the centering pin...

Страница 23: ...l mounted tonometer holder on the stereomicroscope or Fundus VarioView 319300 9120 000 GA GB 240320 17 60 1 2 3 4 A Figure 2 Mounting the AT 030 to the SL 800 slit lamp with swivel mounted tonometer h...

Страница 24: ...e slit lamp 2 Attach the tonometer holder to the slit lamp 3 Attach the applanation tonometer to the base plate of the tonometer holder and fix it by means of the knurled screw 4 Ensure that the cente...

Страница 25: ...19300 9120 000 GA GB 240320 19 60 2 1 1 3 A A Figure 3 Mounting the AT 030 on ZEISS slit lamps with swivel mounted tonometer holder behind the stereo microscope e g SL 120 left and SL 220 right 1 AT 0...

Страница 26: ...the base plate of the tonometer holder and fix it by means of the knurled screw 4 Ensure that the centering pin is securely seated into one of the two alignment holes Select the alignment hole on the...

Страница 27: ...s using the fixed tonometer holder 319300 9120 000 GA GB 240320 21 60 1 2 3 4 5 6 7 8 Figure 4 Mounting the AT 030 to ZEISS slit lamps using the fixed tonometer holder 1 Cap 2 Swivel arm of slit proje...

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Страница 29: ...metry u Utmost caution is also advised with patients suffering from corneal epithelium lesions u Utmost caution is also advised with patients with keratitis infection of the cornea or penetrating eye...

Страница 30: ...s negligible for tonometer measurement With higher astigmatism correct measurements are taken at an angle of about 43 between the major diameter of the ellipse and the direction of the minor principal...

Страница 31: ...t trial measurement on both eyes but take the average of the subsequent three measurements of each eye to obtain a reproducible result u Administer usual anesthesia of the cornea of the patient s eye...

Страница 32: ...of the head rest The patient s head must be pressed firmly against the head rest 2 Insert the clean and disinfected measuring prism into the measuring prism holder as far as it will go Hold the measur...

Страница 33: ...however not to exert inadvertent pressure on the bulbus The fingers should rest only on the bony eye socket 7 Adjust the measuring prism using the joystick of the slit lamp vertically and horizontally...

Страница 34: ...0 10 0 1 33 13 3 1 2 12 0 1 60 16 0 1 4 14 0 1 87 18 7 1 6 16 0 2 13 21 3 1 8 18 0 2 40 24 0 2 0 20 0 2 67 26 7 2 2 22 0 2 93 29 3 2 4 24 0 3 20 32 0 2 6 26 0 3 47 34 7 2 8 28 0 3 73 37 3 3 0 30 0 4...

Страница 35: ...0 GA GB 240320 29 60 Scale reading Pressure mmHg kPa mbar 6 0 60 0 8 00 80 0 6 2 62 0 8 26 82 6 6 4 64 0 8 53 85 3 6 6 66 0 8 80 88 0 6 8 68 0 9 06 90 6 7 0 70 0 9 33 93 3 7 2 72 0 9 60 96 0 7 4 74 0...

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Страница 37: ...ing arm with the measuring prism holder is not at a defined position u When assembling cleaning or transporting the AT 030 appla nation tonometer the measuring element must be set to 2 0 NOTE Damage d...

Страница 38: ...Empty page for your notes...

Страница 39: ...ction no later than 24 months after the end of the first year of use or immediately in the case of impairment of the measurement function by external influ ences If you wish Carl Zeiss Meditec to perf...

Страница 40: ...of the swivel mounted tonometer holder mounted on the stereomicroscope or Fundus VarioView and in case of fixed tonometer holders these checks do not yield satisfying results contact ZEISS Service Due...

Страница 41: ...mounting interface 1 Clamping screw for image focus A Height adjustment 2 Adjusting screw for height adjustment B Coaxial adjustment 3 Swivel arm C Image focus 4 Base plate D Lateral adjustment 5 Ali...

Страница 42: ...er with measuring prism into the vertical center of the field of view by turning the adjusting screw to the right Hold the tonometer so that it cannot rotate laterally Ensure the correct alignment of...

Страница 43: ...changed u Release the knurled screw and remove the tonometer u Set the tonometer with the centering pin into the other alignment hole of the base plate u Retighten the knurled screw u Check whether t...

Страница 44: ...motion range by carefully swiveling the measuring prism from the front to the back stop u If the sharp focus position is not correct loosen the two clamping screws by approx turn u Push the swivel ar...

Страница 45: ...ng prism is not centered in the field of view loosen the two clamping screws on the bottom of the adapter u Adjust the measuring prism by swiveling the swivel arms horizontally in the elongated holes...

Страница 46: ...igure 11 Clamping and adjusting screws on the swivel mounted tonometer holder version b round mounting interface 1 Swivel arm A Height adjustment 2 Clamping screw for height adjustment and coaxial adj...

Страница 47: ...h measuring prism into the vertical center of the field of view by turning the adjusting screw to the right Hold the tonometer so that it cannot rotate laterally Ensure the correct alignment of the me...

Страница 48: ...focus position image focus C u Set the scale on the tonometer to zero u To assess the focus sharpness apply a visible structure to one side of the front surface of the measuring prism e g finger prin...

Страница 49: ...the swivel arm including tonometer backwards in the slot until the sharp focus of the structure visible on one side is in the middle of the motion range When moving the tonometer lift it slightly to a...

Страница 50: ...stment status u If necessary repeat the steps in sections Setting the correct height in the field of view height adjustment A and Setting the lateral middle position in the field of view lateral adjus...

Страница 51: ...weight concentrically onto the measuring prism u Turn the rotary knob slowly from the 0 position until the measuring arm with the weight oscillates weightlessly around its center position Remove the t...

Страница 52: ...Empty page for your notes...

Страница 53: ...met patterns as shown in the following figure will appear These patterns require the slit lamp and thus the measuring prism to be repositioned laterally and vertically Figure 15 Measuring patterns req...

Страница 54: ...isible as they are too large If the slit lamp is pushed too far towards the patient or if the patient moves towards the slit lamp the measuring arm hits against a damping spring The applanation area i...

Страница 55: ...using the control lever Almost the whole circle visible at the top bottom part of semicircle visible at the bottom top The measuring prism is not centered with the eye The eye is too far up down Move...

Страница 56: ...Empty page for your notes...

Страница 57: ...MDD Device class in accordance with the MDD I with measuring function The device is marked with 9 1 2 Classification of the device UMDNS No 16 809 The AT 030 applanation tonometer conforms to the ISO...

Страница 58: ...x 25 mm Weight 245 g 9 4 Ambient requirements Value Ambient conditions for intended use Temperature 10 C to 35 C Relative humidity 30 to 75 no condensation Altitude up to 3000 m above sea level Ambie...

Страница 59: ...n find the ZEISS contact partner for your country on the following website www zeiss com med Use only accessories and spare parts which are approved by ZEISS for this device When using accessories and...

Страница 60: ...Empty page for your notes...

Страница 61: ...with applicable EU guidelines and national regula tions at the time at which the product was brought onto the market the product specified on the consignment note is not to be disposed of via the dom...

Страница 62: ...Empty page for your notes...

Страница 63: ...20 57 60 Glossary D D diopter is the unit of measurement of the refractive power of optical systems kPa Kilopascal 1 kPA 1000 Pa mbar Millibar 1 mbar 1 hPa 100 Pa MDD Medical Device Directive mm Hg Mi...

Страница 64: ...Empty page for your notes...

Страница 65: ...e Index AT 030 319300 9120 000 GA GB 240320 59 60 Index A Ambient conditions 8 D Disposal Electronics 55 Packaging material 55 I Intended user profile 7 O Operating personnel 7 P Product modification...

Страница 66: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Internet www zeiss com med E Mail info meditec zeiss com Specifications subject to change 319300 9120 000 GA GB 240320...

Страница 67: ...319300 9120 000 Inhalt2 GB Contents Instructions for use and disinfection of tonometer measuring prisms 319300 9231 000 AddGA01 GB 240320 2...

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Страница 69: ...Instructions for use and disinfection of tonometer measuring prisms Addendum...

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Страница 71: ...4 1 Conventions in all text areas 5 1 4 2 Conventions in a course of action 6 2 Safety notes 7 2 1 Ambient conditions 7 2 2 Important general advice 7 2 3 Operation environment 7 2 4 Warranty and pro...

Страница 72: ...Empty page for your notes...

Страница 73: ...d disinfection prevents the transmission of diseases to patients and users and mechanical damage This process has been validated by an accredited testing laboratory to protect material and patients 1...

Страница 74: ...essage names the possible consequences u This is a measure with which hazards can be prevented CAUTION This is warning information about hazards that can cause injuries if not avoided The warning mess...

Страница 75: ...ey might otherwise damage the patient s cornea Improper preparation can result in the transmission of diseases to the patient and user as well as damage to the measuring prisms Residue from cleaning a...

Страница 76: ...320 2 5 Validated cleaning and disinfecting agents The following cleaning and disinfecting agents have been used in several validations Cleaning agents Palmolive 0 08 Disinfectants Product Concen trat...

Страница 77: ...e sole purpose of the list below is to provide the user with a choice of suitable disinfectants which may be used for the validation of their own disinfection process ZEISS rejects all liability if an...

Страница 78: ...ride 0 0525 x NaOCl sodium hypo chloride 2 5 x max 100 cycles of 1h NaOCl sodium hypo chloride 10 x max 100 cycles of 1h NaOH sodium hydroxide 1 M 1 mol l x max 100 cycles of 1h H2O2 hydrogen peroxide...

Страница 79: ...8 Disinfectants Tested concentration Alde hyde free Contai ning aldehyde Comments Korsolex extra 4 x Mucocit T 6 x NU CIDEX 1 x PeraSafe 1 x Peraxylens 1 x Perfektan active 2 x Perfektan TB 4 x Sekuse...

Страница 80: ...umber of patients handling etc it is practically impossible to specify how often and or long a measuring prism can be used under safe conditions The measuring prisms carry an expiry date YYYY MM They...

Страница 81: ...all disinfectants that are approved for instrument disinfection and that have been tested for their efficacy against all nosocomially relevant infec tious agents can generally be used as long as they...

Страница 82: ...agents The maximum material compatible exposure time for the disin fectant is 60 minutes Action 1 Take the measuring prisms to be disinfected out of the plastic tray and place them on the lower tray...

Страница 83: ...act surface of the measuring prism must be inspected for contaminants and damage scratches cracks or sharp edges This must be performed with a slit lamp microscope at a medium magnification e g 12x or...

Страница 84: ...le measuring prisms Addendum Instructions for use and disinfection of tonometer measuring prisms 3 3 Rinsing and storage 16 18 319300 9231 000 AddGA01 GB 240320 a b c d f e h g l k j i Figure 2 Steps...

Страница 85: ...Empty page for your notes...

Страница 86: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Internet www zeiss com med E Mail info meditec zeiss com Specifications subject to change 319300 9231 000 AddGA01 GB 240320...

Страница 87: ...Empty page for your notes...

Страница 88: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Internet www zeiss com med E Mail info meditec zeiss com Specifications subject to change 319300 9120 000 DokS GB 240320...

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