Gilras GRU-5000 A User manual

Address: 9990 NW 14ST
Suite 105
Doral,FL33172
Phone:+1‐888‐334‐4640
Fax:+1‐786‐621‐1842
Email:[email protected]

CONTENTS
- I -
CONTENTS
PRECAUTIONS .................................................................................................................................................IV
WARNINGS.........................................................................................................................................................IV
CAUTIONS..........................................................................................................................................................VI
EXPLANATION OF SYMBOLS..................................................................................................................... VII
CHAPTER 1 INTRODUCTION ....................................................................................................................... 1
1.1 GENERAL DESCRIPTION ........................................................................................................................ 1
1.2 INTENDED USE ....................................................................................................................................... 1
1.3 INTENDED LOCATION OF USE ................................................................................................................ 1
1.4 CONTRAINDICATIONS ............................................................................................................................. 1
1.5 EXPECTED SERVICE LIFE....................................................................................................................... 1
1.6 SOFTWARE VERSION ............................................................................................................................. 1
CHAPTER 2 SPECIFICATIONS..................................................................................................................... 2
2.1 WORKING CONDITIONS.......................................................................................................................... 2
2.2 MAIN SPECIFICATIONS........................................................................................................................... 2
2.3 SAFETY................................................................................................................................................... 2
2.4 STORAGE AND TRANSPORTATION CONDITIONS.................................................................................... 2
2.4.1 Storage Conditions....................................................................................................................... 2
2.4.2 Transportation Conditions ......................................................................................................... 3
2.5 CLASSIFICATION..................................................................................................................................... 3
CHAPTER 3 INSTALLATION ......................................................................................................................... 4
3.1 STRUCTURE............................................................................................................................................ 4
3.2 ENVIRONMENTAL REQUIREMENTS......................................................................................................... 5
3.3 CONNECTION.......................................................................................................................................... 5
3.3.1. Connection of Probe ................................................................................................................ 5
3.3.2. Disconnection of Probe........................................................................................................... 5
3.3.3. Connection of Power Supply................................................................................................. 6
3.3.4. Disconnection of Power Supply............................................................................................ 6
3.3.5. Connection of Foot Switch..................................................................................................... 7
3.3.6. Replacement of Printing Paper.............................................................................................. 7
CHAPTER 4 OPERATION............................................................................................................................... 8
4.1 STARTUP AND SHUTDOWN..................................................................................................................... 8
4.1.1. Check before Startup............................................................................................................... 8
4.1.2. Startup Procedure..................................................................................................................... 8
4.1.3. Check before Use...................................................................................................................... 8
4.1.4. Shutdown Procedure ............................................................................................................... 9
4.2 INTERFACE INTRODUCTION.................................................................................................................... 9
4.2.1. Startup Interface........................................................................................................................ 9
4.2.2. ASCAN Interface...................................................................................................................... 10

CONTENTS
- II -
4.2.3. Patient Interface (Patient Information Interface)............................................................. 12
4.2.4. MENU Interface........................................................................................................................ 14
4.2.5. IOL Interface............................................................................................................................. 14
4.2.6. SETUP Interface ...................................................................................................................... 17
4.2.7. DATA BASE Interface............................................................................................................. 18
4.3 OPERATION .......................................................................................................................................... 19
4.3.1 Positioning ...................................................................................................................................... 19
4.3.2 A Biometer Unit.............................................................................................................................. 19
4.3.3 DATA BASE..................................................................................................................................... 28
4.3.4 Display of Saved Information ..................................................................................................... 29
4.3.5 Amendment and Storage of Parameters, and Clock Setting.............................................. 30
CHAPTER 5 CLEANING, DISINFECTION AND STERILIZATION......................................................... 34
FOR EUROPE:............................................................................................................................................... 34
5.1 HOW TO PREVENT CROSS-INFECTION................................................................................................. 34
5.2 CLEANING,DISINFECTION OF EYE CUP............................................................................................... 34
5.3 STERILIZATION PROCEDURE –PRE-STERILIZATION AND STERILIZATION OF THE PROBES ............... 34
5.4 PREPARATION OF STERILIZATION AGENT............................................................................................ 35
5.5 STANDARD METHOD ............................................................................................................................ 36
FOR U.S.A ...................................................................................................................................................... 39
5.6 CLEANING OF THE MAIN UNIT OF GRU-5000A ................................................................................. 39
5.7 HOW TO PREVENT CROSS-INFECTION ................................................................................................ 39
5.8 METHOD ............................................................................................................................................... 39
5.8.1 Preparation...................................................................................................................................... 39
5.8.2 Thorough Cleaning........................................................................................................................ 40
5.8.3 Disinfection ..................................................................................................................................... 40
5.8.4 Rinsing after Disinfection............................................................................................................ 41
CHAPTER 6 LABELING................................................................................................................................ 42
6.1 EXTERNAL LABEL ................................................................................................................................ 42
6.2 INTERNAL ID......................................................................................................................................... 42
CHAPTER 7 MAINTENANCE, ATTENTIONS AND SIMPLE DEFECTS TREATMENT..................... 43
7.1 MAINTENANCE AND ATTENTIONS TO INSTRUMENT ............................................................................. 43
7.2 MAINTENANCE AND ATTENTIONS TO PROBE....................................................................................... 43
7.3 MAINTENANCE OF LCD SCREEN......................................................................................................... 44
7.4 CHECK BEFORE USE............................................................................................................................ 44
7.5 TROUBLE SHOOTING............................................................................................................................ 45
CHAPTER 8 SERVICE AND SUPPORT INFORMATION........................................................................ 46
8.1 WARRANTY........................................................................................................................................... 46
8.2 ACCESSORIES AND MATERIALS........................................................................................................... 46
8.2.1 Consumables ........................................................................................................................... 46
8.2.2 Detachable Parts..................................................................................................................... 46
8.2.3 Materials.................................................................................................................................... 46

CONTENTS
- III -
8.3 SOFTWARE UPDATE AND SERVICES.................................................................................................... 46
ANNEX A PRUDENT USE STATEMENT.................................................................................................... 48
A.1 STATEMENT .......................................................................................................................................... 48
A.2 PRINCIPLE OF ALARA（AS LOW AS REASONABLY ACHIEVABLE）................................................ 48
ANNEX B PROMPT MESSAGE................................................................................................................... 49
ANNEX C.1 ACOUSTIC OUTPUT REPORT (IEC60601-2-37)............................................................... 50
ANNEX C.2 ACOUSTIC OUTPUT REPORTING TABLE ........................................................................ 51
ANNEX D GUIDANCE AND MANUFACTURER’S DECLARATION...................................................... 52
ANNEX E IOL FORMULA ............................................................................................................................. 56
ANNEX F REFERENCES.............................................................................................................................. 58

Precautions and Warnings
- IV -
PRECAUTIONS
The device should be operated by trained technicians.
It is prohibited to use the device on patients with eye trauma, inflammation or infection.
Please read the manual carefully before installation and operation
Please refer to Chapter 5. Cleaning, Disinfection and Sterilization to avoid cross-infection
while using.
Disconnect AC power before cleaning the housing case.
Please refer to Chapter 7. Maintenance, Attentions and Simple Defects Treatment for
maintenance attentions.
WARNINGS
The customer is fully responsible for maintenance and management of the instrument after
purchasing.
Do not make any modification to the software and hardware of the device without
authorization.
The power adaptor provided with the device meets the safety standard of medical electrical
devices. If damaged, contact the Manufacturer to purchase. Use of other adaptors may cause
safety risk.
The manufacturer won't be responsible for any damage or injury caused by any failure to
follow the instructions in the User Manual.
The manufacturer reserves the right to modify equipment characteristics without previous
notice under FDA Laws and MDD (93/42/EEC) Regulation.
The quality guarantee of the device will be invalid if it is opened (even partially), modified or
repaired in any way by anyone who is not authorized by the manufacturer.
____________________
This device is not intended for therapeutic use.
It is prohibited to use the device on patients with eye trauma, inflammation or infection.
The device should be used cautiously on patients without independent behavior abilities or
who are highly sensitive to contacting measurements, whose ineffective cooperation may
result in inaccurate measurements.

Precautions and Warnings
- V -
According to FDA laws, the GRU-5000 is a prescription Device and is to be used by or under
the supervision of a licensed physician.
This device is not intended for fetal use.
While plugging in the probe, make sure the red mark on the probe align with the red mark on
the socket.
While unplugging the probe, please be sure you are pulling the connector instead of the
cable.
Do not scratch the surface of the probe.
Do not drop the probes.
If the probe drops during using or moving, check the top and the housing of probe carefully,
and then check if it works well. Stop using if there is any problem and contact the
manufacturer or local distributor for service.
Warnings of predicable potential hazards are contained in the User Manual. Please maintain
vigilance at any time to those unpredictable hazards. The manufacturer won’t be responsible
for damages and losses caused by negligence or ignorance of the preventive measures in the
User Manual.
The assembly, expanding, readjustment, improvement and repair should be operated by
personnel authorized by the manufacturer. Do not open the housing for repair without
permission. The manufacturer won’t be responsible for the consequences of safety and
effectiveness caused by unauthorized repair.
Keep the original package properly. All detachable accessories should be put into the original
package before moving and transportation.
Without written consent of the manufacturer, no individual or organization is allowed to copy,
modify, or translate any part of the User Manual.
For any question, please contact the Manufacturer or your Local Distributor

Caution
- VI -
CAUTIONS
HOW TO PREVENT CROSS-INFECTION
It is prohibited to use the device on patients with eye trauma, inflammation or infection.
Between uses on different patients, the probe and eye cup must be thoroughly cleaned and
disinfected to prevent cross-infection.
The Manufacturer advocates a preventive action and a cleaning procedure in Chapter 5.
Cleaning, Disinfection and Sterilization.
____________________
CAUTION
Federal (US) Law restricts this device to sale by or on the order of a physician.
The GRU-5000 IOL calculator will calculate negative IOL values if such is predicted by the
data input.
These are displayed with a minus sign "-". Do not ignore this sign.
_____________________
TISSUE EXPOSURE TO ULTRASOUND ENERGY:
The GRU-5000 is designed for use in ophthalmology only.
While the manufacturer is not aware of any reports of adverse effects from using ophthalmic
ultrasound scanner, even at FDA pre-enactment levels, no other use is intended or implied.
The system controls limit of the output energy within the parameters specified for its intended
purpose. Please refer to Annex A of the User Manual.
No control of ultrasound energy is available to the users other than the duration of exposure,
considering the current concern for possible unknown hazards, and despite the extremely low
output intensities used in this ultrasound system.
The manufacturer recommends that patients’ exposure time during measurement be
minimized.

Explanation of Symbols
- VII -
EXPLANATION OF SYMBOLS
Front Panel
Power On or Power Off
OPEN Paper Housing Switch
PRINT Thermal Printer
Rear Panel
Symbol of "Type B"
Refer to User Manual
Serial Number
CE Mark
Manufacturer
FOOT SWITCH Foot Switch Socket
Power Input Socket
Right Panel
A-Probe A Biometric Probe Socket
User Manual
NOTE! Important information that
operator must read carefully.
IPX1/IPX7 The degree of protection against
ingress of liquids

Chapter 1 Introduction
- 1 -
Chapter 1 Introduction
1.1 General Description
The GRU-5000 A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring instrument
based on pulse reflection. It comprises A Mode Eye Axis Biometric Parameter Measuring Unit (A
Biometer).
The A Biometer consists of a 10MHz A-Scan probe (probe model: Prb1000A/10-C) and an axis
biometric parameter measuring unit. The axis is usually divided into three segments: anterior
chamber, lens and vitreous body. Since the tissue within the eye varies in different areas, the
acoustic velocity through these areas is also different. The summation of these three segments
(ACD + LENS + VITR) provides the axial length (AL). Based on the interface reflections of these
three different tissues, the ultrasonic A-biometry measures the transmitting time of ultrasound
through each tissue and calculates the length of each segment to finally get the axial length.
The GRU-5000A has a built-in Thermal Printer, used to print out patient information, A-Scan
measuring waveform, IOL calculating parameter and result.
The built-in memory of the GRU-5000A can store up to 180 patients' records.
1.2 Intended Use
The GRU-5000A is intended for axial biometric parameter measurement in clinical ophthalmology.
1.3 Intended Location of Use
The GRU-5000A is suitable to be applied in hospitals and ophthalmology clinics.
As the foot switch's protective degree against ingress of liquids is IPX1, it is not suitable to be used
in operating room and other locations where it is easy to splash liquid.
1.4 Contraindications
It is prohibited to use the device on patients with eye trauma, inflammation or infection.
1.5 Expected Service Life
Based on the experience of products sold (and considering technology update cycle), as well as
the aging of the major part –transducer will probably reduce the basic performance, the product's
expected service life is determined as five years according to the normal usage of six hours each
working day. (Service life may extend if the major parts, like probe, are returned to manufacturer
for update.)
1.6 Software Version
V1.0.0.10