Nidek Medical PM-700 User manual

OPERATOR’S MANUAL
PD METER
PM-700

NIDEK CO., LTD. : 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN
(Manufacturer) Telephone: [phone]
URL: https://www.nidek.com/
NIDEK INC. : 2040 Corporate Court, San Jose, CA 95131, U.S.A.
(United States Agent) Telephone: [phone] (USA Only)
URL: https://usa.nidek.com/
NIDEK S.A. : Europarc, 13 rue Auguste Perret, 94042 Créteil, FRANCE
(EU Authorized Representative) Telephone: [phone]
URL: http://www.nidek.fr/
2020-07
35241-P902-C7
Printed in Japan
Original instructions
2014 NIDEK CO., LTD.
C

I
35241-P902-C7
Before Use
This Operator's Manual contains information necessary for the
operation of the NIDEK PD Meter PM-700.
This manual includes operating procedures, safety precautions,
specifications, and information about accessories and mainte-
nance. This manual is necessary for proper use. Especially, the
safety precautions and operating procedures must be thoroughly
understood prior to the operation of the device.
Keep this manual handy for reference.
If you encounter any problems or have questions about the
device, please contact NIDEK or your authorized distributor.

II
Table of Contents
1. SAFETY PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 For Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
1.2 Safety Precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
1.3 Usage Precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -2
1.4 Labels and Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -5
2. BEFORE USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Device Outline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
2.2 Device Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
2.3 Packed Contents - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12
2.4 Before First Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -13
2.4.1 Attaching hand strap - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -13
2.4.2 Attaching neck strap (optional) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
2.4.3 Setting measurement increments and indication switching - - - - - - - - - - - - - - - -17
3. OPERATING PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.1 Button Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19
3.2 For Proper Measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -21
3.3 Startup and Shutdown - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22
3.3.1 Device startup and check before use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22
3.3.2 After use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -22
3.3.3 Auto-off function - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -23
3.4 Measurement Method - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 24
3.4.1 Measurement without eye occlusion - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -24
3.4.2 Measurement with one eye occluded - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 27
4. MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.1 Troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -29
4.2 Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -30
4.2.1 Cleaning the exterior - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -30
4.2.2 Cleaning the nose pad - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 30
4.2.3 Cleaning the forehead arm - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -31
4.2.4 Cleaning the measuring window - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 31
4.3 Replacing Batteries - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 32
4.4 List of Consumables - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -34

III
:
5. SPECIFICATIONS AND TECHNICAL INFORMATION . . . . . . . . 35
5.1 Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 35
5.2 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 37
6. INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

IV
:

1
1 SAFETY PRECAUTIONS
1.1 For Safe Use
CAUTION! U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a
licensed eye care practitioner.
1.2 Safety Precautions
For safe use of this device, read this manual.
Cautions for safety and operating procedures must be thoroughly understood before using
this device.
In this manual, signal word is used to designate the degree or level of the safety alert.
The definition is as follows:
CAUTION
Indicates a potentially hazardous situation which, if not avoided, may result in minor or mod-
erate injury or property damage accident.
Even cases indicated by CAUTION may result in serious injury under certain conditions.
Safety precautions must be strictly followed at all times.

2
SAFETY PRECAUTIONS: Usage Precautions
1.3 Usage Precautions
Before Use
WARNING
• If any serious device-related incident occurs, report it to NIDEK and the competent authority in the
country where the user or patient, or both reside.
CAUTION
• Do not use the device in any manner other than its intended purpose.
NIDEK will not be responsible for accidents or malfunctions caused by carelessness.  “O Intended
Use” (page 7)
• The cautions for safety and operating procedures must be thoroughly understood before using the
device.
Use of the device outside the scope of this operator’s manual may cause unanticipated failure or
adverse events.
• Use the accessories specified by NIDEK only.
Using the components outside the operator’s manual may cause unanticipated failure or adverse
events.
• Never modify the device. Never touch the inside of the device.
Doing so may result in an electric shock or device malfunction.
No components other than the battery in the PM-700 can be replaced by the user.
• Do not store the device in a place where it may get wet.
Doing so may result in an electric shock or device malfunction.
• Use the PM-700 in the following environment.
•Environmental conditions during use
 “O Specifications” (page 35)
• Before using the device, perform check before use in “3.3.1 Device startup and check before use”
(page 22).

3
SAFETY PRECAUTIONS: Usage Precautions
During Use
After Use
CAUTION
• Before measuring each patient, clean the nose pad and forehead arm with a cloth dipped in alcohol
for disinfection.
• Perform visual and operation checks before using the device. If any abnormality is found, do not use
the device.
Continued use of the device under such abnormal conditions may affect the data accuracy. Unexpected
malfunction or faulty diagnosis may induce unexpected health hazards.
• Prior to use, adequately explain the measurement purpose and method to the patient.
• Do not perform servicing or maintenance on the device during use.
• When moving the forehead arm, take care not to get fingers pinched.
If a finger gets caught, injury may occur.
• Perform measurement with the patient eye sufficiently fixated and eyelids are fully open.
Failure to do so may result in improper measurement results.
• Be careful so that the measuring window is not soiled with grime or fingerprints. Check that there is
no grime on the window before measurement.
If the measuring window is soiled, proper measurement value may not be obtained.
• Hold the PM-700 and measure the pupillary distance so that the device is not tilted against patient's
face.
If the device is tilted, proper measurement value may not be obtained.
• Measure the pupillary distance in a location where the measuring window is not exposed to strong
external light such as sunlight or spot light.
If a strong external light enters, proper measurement value may not be obtained.
• When using the device, use the hand strap or the optional neck strap to prevent it from being
dropped. Replace the strap if it is damaged or worn.
Otherwise the device may be dropped causing injury or malfunction. If any problem occurs in the accu-
racy or function due to dropping, contact NIDEK or your authorized distributor.
CAUTION
• After use, clean the nose pad and forehead arm using a cloth dipped in alcohol for disinfection.
• Remove batteries from the battery case when the device will not be used for a prolonged periods.
Failure to do so may cause a device malfunction or damage the periphery due to leakage.

4
SAFETY PRECAUTIONS: Usage Precautions
Maintenance
Disposal
CAUTION
• When the device is sent back to NIDEK for repair or maintenance, disinfect it by wiping the surfaces
(especially, the areas that came into contact with patients) of the device with a clean cloth damp-
ened with ethyl alcohol for disinfection.
• Only service personnel properly trained by NIDEK are allowed to disassemble, repair, or modify the
device.
NIDEK assumes no responsibility for accidents resulting from improper servicing.
• Remove any dust on the measuring window with a blower brush before wiping the windows.
If the measuring window is wiped with dust on it or is rubbed with excessive force, the surface may be
scratched.
• Do not clean the windows with wet cloth such as cleaner.
The surface may become smudged or the coating damaged.
• Never use an organic solvent such as paint thinner or the abrasive cleanser to clean the device.
The surface may be ruined.
• Do not use old and new batteries or batteries for other model together.
The PM-700 may not work normally or it may cause a device malfunction or damage the periphery due
to leakage.
• Do not use the device past its service life.
Even under the proper maintenance, the targeted device reliability and safety may not be maintained.
CAUTION
• Follow local governing ordinances and recycling plans regarding disposal or recycling of device
components when disposing of the device.
It is recommended to entrust the disposal to a designated industrial waste disposal contractor.
Inappropriate disposal may contaminate the environment.
• The disposal method of batteries varies according to the government. Follow local ordinances
regarding disposal of them.
Inappropriate disposal may contaminate the environment.
• When disposing of packing materials, sort them by material and follow local governing ordinances
and recycling plans.
Inappropriate disposal may contaminate the environment.

5
SAFETY PRECAUTIONS: Labels and Symbols
1.4 Labels and Symbols
To call attention to the user, label and indications are displayed on the device. If labels are curling up
or characters fade and become barely legible, contact NIDEK or your authorized distributor.
Indicates that the operator is advised to refer to the related instructions in the operator's
manual.
 “ Before Use” (page 2)
Indicates that the PM-700 is classified as a device with a Type B applied part.
The applied parts are the nose pad and forehead arm.
 “2.2 Device Configuration”
(page 9)
Indicates the manufacturer.
Indicates the date of manufacture.
Indicates that this product is to be disposed of in separate collection of electrical and
electronic equipment in EU.
Indicates the switch that brings the device into the stand-by condition.
For the PM-700, the device is in the stand-by condition when the display is off.
Medical device
EU Authorized Representative
MD
EC REP

6
SAFETY PRECAUTIONS: Labels and Symbols

7
2 BEFORE USE
2.1 Device Outline
The PD meter model PM-700 (referred to as “device” in this manual) is a pupillary distance meter
improved with a built-in computer and LCD digital display.
O Intended Use
The PD meter model PM-700 is intended to measure the pupillary distance for proper wear of the
spectacle lenses.
O Intended patient population
•Age
Except babies and infants (under 3 years old)
•Health condition
Able to answer the operator’s questions
•Conditions - Visual function
One or both eyes are normal or have disease.
Eyes that have lost the visual function are not targeted.
Person who wants to wear glasses
•Conditions - Other
Person whose pupillary distance of a single eye is 23.5 mm or more and 41.5 mm or less
O Intended user profile
Any qualified personnel such as ophthalmologists, nurses, ORT, OD, optician facility staff, or optome-
trists (irrespective of nationality, culture, or style of dress)
O Principles
The patient focuses on the fixation target through the measuring window in the device. An apparent
distance between the patient’s eye and fixation target is preset to 1 m using the convex lens placed
between them. The examiner looks at the patient’s eye through the eyepiece, and aligns the hairlines
on the LCD with the LED reflection point on the cornea.
The aligned hairline positions are indicated on the display as the pupillary distance.
The apparent viewing distance is set to 1 m. The interpupillary distance is calculated according to the
working distance set with the Distance setting button .
The PM-700 displays the pupillary distance for a vertex distance (VD) of 12 mm.
Vertex distance: Distance between the corneal vertex to the spectacle lens when the patient
wears the glasses

8
BEFORE USE: Device Outline
When obtaining the pupillary distance for a vertex distance other than 12 mm, convert the value with
the following formula.
PD = PD ∞ ×
PD: Pupillary distance (mm)
PD ∞ : PD value (mm) when the working distance is set to ∞
WD: Working distance (mm)
VD: Vertex distance (mm)
WD − VD
WD + 13

9
BEFORE USE: Device Configuration
2.2 Device Configuration
1Eyepiece
The examiner looks at the patient’s eyes through this
eyepiece.
2Eyepiece cover
3Strap holes
Holes for attaching the hand strap or the optional neck strap.
Number Name Explanation
1) Hairline
Vertical line displayed aligned on the patient's eye
Move to the right and left over the eye to align with the corneal
reflection point.
2) Corneal reflec-
tion point LED reflection light on the patient's cornea
4
3
2
1
5 6 7 8
10 9
Patient's right eye Patient's left eye
1) 2) 2) 1)

10
BEFORE USE: Device Configuration
4Display
Displays measured PD data (right eye PD, binocular PD, left eye PD).
PD: Pupillary Distance
In addition to the measured value, the following are indicated.
Battery replacement indicator……
Working distance………………… -
Measurement mode……………… / /
5Distance setting button
Sets the working distance.
The distance can be cycled from among 8 steps, 30cm, 35cm, 40cm, 50cm, 65cm, 1m, 2m, and ∞. The dis-
tance advances each time is pressed.
6Right PD measurement button
Moves the hairline (vertical line) displayed on the patient's right eye.
7Power button
Turns on or off the power.
Press and hold this button for two seconds to turn off the device.
Owing to the Auto-off function, the power will turn off automatically after a short while even if a user forgets
to turn it off manually.
 “3.3.3 Auto-off function” (page 23)
8Forehead arm
Place it against the patient’s forehead to stabilize the
position of the main body.
If the forehead arm is not used, it can be folded under
the bottom.
Pressing the right side of the button moves the hairline towards the nose.
Pressing the left side of the button moves the hairline towards the temple.
BATTBATT
Binocular PD (pupillary distance)
Right eye PD Left eye PD
Battery replacement
indicator
Working distance
Measurement mode

11
BEFORE USE: Device Configuration
9Left PD measurement button
Moves the hairline (vertical line) displayed on the patient's left eye.
10 R/L button
Used to occlude either side of the patient's eyes.
Each pressing changes the setting in the order of binocular open , right eye measurement (left
occluded), and left eye measurement (right occluded).
To change the indication of the measured value, press and hold this button for two seconds. (0.1 mm / 0.5
mm)
11 Measuring window
The patient focuses on the green fixation target
through this window.
12 Nose pad
Place this nose pad against the patient’s nose lightly.
The nose pad can be replaced.
13 Battery cover
Pressing the right side of the button moves the hairline towards the temple.
Pressing the left side of the button moves the hairline towards the nose.
12
11
13
Fixation target
• Parts that come into contact with the patient during refraction are composed of the following materi-
als:
Nose pad: silicon rubber
Forehead arm: stainless steel
Buttons, body, and eyepiece cover: ABS resin
Hand strap: nylon

12
BEFORE USE: Packed Contents
2.3 Packed Contents
The following are included in the standard configuration. Check the contents before use.
Parts name Quantity Appearance
Alkaline AA battery (LR6) 2 units
Nose pad (spare) 1 unit
Hand strap 1 unit
Operator's manual 1 unit

13
BEFORE USE: Before First Use
2.4 Before First Use
Before using the device, attach the following parts and conduct the following settings.
2.4.1 Attaching hand strap
To attach the hand strap, follow the procedures below.
The strap holes are on the right and left sides as viewed from the examiner. Attach the strap to the
side easy to use.
1 Take out the strap, buckle, and holder from
the bag.
2 Pass the strap through the buckle.
The buckle has an inside and an outside. Insert the
strap from the grooved side.
3 Pass the strap through the holder.
Attaching strap See “2.4.1 Attaching hand strap” (page 13) or “2.4.2 Attaching neck
strap (optional)” (page 15).
Attaching batteries See “4.3 Replacing Batteries” (page 32).
Setting measurement incre-
ments and indication switching
See “2.4.3 Setting measurement increments and indication switching”
(page 17).
Hand strap
Buckle Holder
Holder
Grooved side
of buckle

14
BEFORE USE: Before First Use
4Pass the end of the strap through the strap
hole from the side.
There are strap holes on the right and left sides of the
main body. Pass the strap through the desired hole.
5Bend the strap and pass it through the
holder.
6Pass the strap through the buckle. (inside of
the buckle)
7Adjust the buckle position to adjust the strap
length.
8Take up any slack and check that there is no
play in the strap.
• Be sure to extend off the strap end at least 1 cm
through the buckle.
If the extended part of the strap is too short, the
strap may come loose from the buckle.
1 cm or longer