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Haag-Streit AT 900 User Manual

Haag-Streit AT 900
21 pages
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1
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7006000‑04270 – 2022 – 09
INSTRUCTIONS FOR USE
Applanation tonometer
AT 900
®
/ AT 870
27. Edition / 2022 – 09
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Haag-Streit AT 900 Specifications

General IconGeneral
TypeSlit Lamp
MountingTable-mounted
IlluminationLED
Slit Width0 to 14 mm
FiltersCobalt blue
Power SupplyAC 100-240V
Magnification10x

Summary

Preface

Safety Warning: Trained Personnel Required for Tonometry

Safety warning regarding who can perform tonometry.

Safety Warning: Read Manual Before Use

Crucial safety advice to read manual before product use.

USA Regulatory Note: Physician or Licensed Practitioner Order Required

Regulatory note for USA market concerning device sales.

1 Safety

1.1 Comments on Instructions for Use

Notes on the use of decimal separators in the instructions.

1.2 Ambient Conditions for Device Operation

Specifies operating and storage environmental conditions for the device.

1.3 Shipment and Unpacking Procedures

Procedures for safe handling and unpacking of the device during shipping.

1.4 Installation Warnings

Important warnings regarding device installation and modifications.

1.5 Operation and Environment Guidelines

Examination by Medical Professional and Device Usage

Safety guidelines for performing examinations and device usage.

Operator Qualifications and Responsibilities

Notes on operator qualifications and responsibilities for device use.

1.6 Disinfection Requirements

Tonometer Disinfection Clarification

Clarification on the disinfection requirements for the tonometer itself.

1.6.1 Measuring Prism Cleaning and Disinfection

Detailed procedures and warnings for cleaning and disinfecting the measuring prism.

1.6.2 Visual Inspection of Measuring Prisms

Danger: Do Not Use Damaged Measuring Prisms

Critical danger warning about using damaged measuring prisms.

1.6.3 Reusable Measuring Prism Usage Period

Warning on Reusable Prism Usage Duration

Warning and guidelines on the safe usage period for reusable prisms.

1.6.4 Tonosafe Disposable Prisms

Tonosafe Introduction for Hygiene

Introduction to Tonosafe disposable prisms for hygiene and convenience.

1.6.5 Monthly Device Checks

Monthly Tonometer Check Requirement

Requirement for monthly checks and actions after external force application.

1.7 Warranty and Product Liability

Product Use Conditions and Warranty Voidance

Conditions for product use and warranty voidance due to improper handling.

1.8 Reporting Obligation

Report Serious Incidents to Authorities

Obligation to report serious incidents involving the device to authorities.

1.9 Description of Symbols

2 Intended Purpose and Use

2.1 Device Description and Intended Users

Description of the applanation tonometers and who can use them.

2.2 Medical Purpose, Indications, Contraindications

Details medical purpose, indications for glaucoma, and contraindications.

2.3 Principles of Operation and Environment

Explains operation principles and suitable operating environments.

2.4 Clinical Benefit

Highlights the clinical benefits of Goldmann Applanation Tonometry.

3 Introduction

3.1 Overview of Tonometer Components

Provides a general overview and lists key components of the tonometer.

4 Device Assembly and Installation

Warning: Professional Installation Required

Critical warning that only trained specialists should perform installation and repairs.

4.1 AT 900 Model R Assembly

Step-by-step assembly instructions for the AT 900 model R on BM 900 slit lamp.

4.2 AT 900 Model T Installation

Instructions for mounting the AT 900 model T on the slit lamp.

4.3 AT 900 Model BQ Connection

Instructions for connecting the AT 900 model BQ to the slit lamp.

4.4 Tonometer AT 870 Note

Note regarding compatibility and instructions for other manufacturers' devices.

4.5 Slit Lamp Tonometer Compatibility

Tonometer Model Compatibility Chart

Table detailing compatibility of different Haag-Streit slit lamps with AT 900 and AT 870 tonometers.

4.6 Description of Tonometer Models

AT 900 Model R Installation and Observation

Description of AT 900 R model installation and observation method.

AT 900 Model T Positioning and Observation

Description of AT 900 T model positioning and observation.

AT 900 Model BQ Features and Examination

Description of AT 900 BQ model features and examination method.

AT 870 Model Positioning and Operation

Description of AT 870 model positioning and operation.

5 Commissioning Procedures

Warning: Read Safety Chapter Before Operation

Crucial warning to read safety chapter before operating the device.

Smooth Operation with Original Accessories

Note on ensuring smooth operation with original accessories.

6 Operation

Warning: Prism Cleaning After Each Use

Warning regarding mandatory cleaning and disinfection of reusable prisms.

6.1 Astigmatism Measurement Guidance

Guidance on measuring astigmatism and its effect on measurement methodology.

6.2 How Intraocular Pressure is Measured

Explanation of the Goldmann method for measuring intraocular pressure.

6.3 Patient Preparation for Examination

Instructions for preparing the patient, including anaesthesia and fluorescein application.

6.4 Patient Instructions During Examination

Guidance for patients on how to position themselves and cooperate during the examination.

6.5 Slit Lamp and Tonometer Preparation

Steps for preparing the slit lamp and tonometer before measurement.

6.6 Measuring Correctly

Ensure Tonometer Arm Freedom of Movement

Note on ensuring the tonometer arm moves freely without obstruction.

Warning: Eyepiece Adjustment Affects Accuracy

Warning about incorrect eyepiece adjustment leading to inaccurate measurements.

6.7 Sources of Measurement Error

Fluorescein Band and Distance Errors

Identifies errors related to incorrect fluorescein bands and patient distance.

Positional Errors: Right/Left and High/Low

Details errors caused by incorrect horizontal and vertical positioning.

Incorrect Pressure Application Errors

Explains errors due to applying incorrect pressure during measurement.

6.7.3 Position Too High or Low

Identifying High/Low Position Error Images

Describes error images for high/low positioning and correct setting.

6.7.4 Incorrect Pressure Measurement

Identifying Incorrect Pressure Error Images

Describes error images for incorrect pressure and correct setting.

7 Technical Data

7.1 Applanation Tonometer AT 900 Specifications

Provides technical specifications for the AT 900 applanation tonometer.

7.2 Applanation Tonometer AT 870 Specifications

Measuring Force and Installation for AT 870

Details measuring force and installation for the AT 870.

AT 870 Measurement Range and Deviation

Specifies the measurement range and deviation for the AT 870.

AT 870 Backlash Width and Net Weight

Lists backlash width and net weight for the AT 870.

8 Maintenance Procedures

Warning: Professional Maintenance Required

Critical warning about performing maintenance and repairs by trained personnel only.

8.1 Device Repairs and Service

General guidance on device repairs and the need for qualified technicians.

8.2 Cleaning and Disinfection of Tonometer

Procedures for cleaning and disinfecting the tonometer housing and sensor arm.

8.3 Checking the Tonometer AT 900

Requirement for Monthly AT 900 Checks

Requirement for monthly checks of the AT 900 tonometer.

Sending Defective AT 900 Devices for Repair

Instruction to send defective devices for repair to the representative.

AT 900 Drum Position 0 Check Procedure

Procedure for checking drum position 0 on the AT 900.

AT 900 Drum Position 2 Check Procedure

Procedure for checking drum position 2 on the AT 900 using control weight.

8.4 Checking the Tonometer AT 870

Requirement for Monthly AT 870 Checks

Requirement for monthly checks of the AT 870 tonometer.

Sending Defective AT 870 Devices for Repair

Instruction to send defective devices for repair to the representative.

AT 870 Drum Position 6 Check Procedure

Procedure for checking drum position 6 on the AT 870.

AT 870 Drum Position 5.9 Check

Procedure for checking position 5.9 on the AT 870 drum.

AT 870 Drum Position 6.1 Check

Procedure for checking position 6.1 on the AT 870 drum.

Tonometer Drum Position Verification

Checking Drum Positions 0, 1.95, and 2.05

Procedures for verifying drum positions 0, 1.95, and 2.05.

Checking Drum Positions 2 and 6

Procedures for verifying drum positions 2 and 6.

Checking Drum Positions 5.9 and 6.1

Procedures for verifying drum positions 5.9 and 6.1.

9 Appendix

9.1 Accessories, Parts, and Consumables

Lists available accessories, functional parts, detachable parts, and consumables.

9.2 Original Prism and 9.3 Tonosafe Prisms

Information on original prisms and Tonosafe disposable prisms.

9.4 Legal Regulations, Classification, and Disposal

Covers legal aspects, classification, and disposal guidelines for the device.

9.7 Observed Standards

Lists the standards observed in the development and design of the device.

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