Red-Eye Intravenous Drip Monitor SW 8. 02L User Manual Issue 3

Page 2

1: Introduction.

In this manual you will find instructions on how to operate

the Red-Eye Ô Intravenous Drip Monitor safely and

correctly, how to care for it and what to do should anything

go wrong. Please take the time to read all the information

before you use the Drip Monitor and follow any warnings

printed in bold type.

The Drip Monitor is a medical device and has been

carefully designed and made to achieve a high level of

safety protection. In making a decision when to use the

Red-EyeÔ Drip Monitor the performance specification

should be considered along with the treatment being

applied.

Please ensure that this Instruction Manual is given to

the person who will be responsible for using the Drip

Monitor before using the equipment.

What is the Red-Eye Ô Intravenous Drip Monitor

The Red-Eye™ Intravenous Drip Monitor is a battery

operated monitor which displays and records the flow of

fluid from a gravity-feed intravenous drip bag via an

administration set. It is suitable for monitoring blood, blood

products, antibiotics and saline or dextrose based fluids.

The Drip Monitor can also be programmed in advance to

remain in use throughout a series of infusions. A printed

record can be retained for patient records.

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Page 3

Functions of Red-Eye™

Constant monitoring:

The Drip Monitor displays and records the following for

each patient:

Ø

Ø

Ø

Ø

Rate of flow in millilitres per hour

Total fluid delivered (in millilitres)

Time and date

Patient ID Number

Early warning:

The Drip Monitor provides an early warning in the form of

a red light and an optional audible alarm when:

Ø

Ø

Ø

Ø

The flow deviates from the pre-set rate

The required volume of fluid has been

delivered by infusion.

The fluid bag becomes empty.

The flow is interrupted for some other

reason, e.g. the venflon has tissued

Automatic patient records:

Recorded data of each IV infusion can be downloaded

easily to a computer (PC) to complete the patient records.

Simple to operate:

Monitoring of the IV drips is by optical means. The Drip

Monitor calculates fluid flow (ml/h) without the need to use

complicated, time-consuming formulae. Keypads are

“membrane type” to prevent fluids infiltrating into the

equipment and they have a touch sensitive feel for

confident operation.

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2: How to use the Drip Monitor.

Do’s and Do Nots

DO

DO

DO NOT

DO NOT

DO NOT

DO NOT

DO NOT

check the battery daily (the icon is updated

on the screen every 15 seconds).

recharge overnight once finished using the

device.

use this device without understanding

these instructions.

get the Drip Monitor wet. It is not

waterproof and the performance will be

affected.

open the Drip Monitor casing to look

inside. The performance will be affected.

use it outside the Drip Monitor’s

temperature range. The performance will

be affected.

bend the sensor lead into an acute angle.

The performance will be affected.

Charging the Batteries.

The batteries are nickel metal hydride cells. The battery icon on the front

screen shows the condition of the batteries. The charger supplied with the

device will recharge to full power in 5 hours. Once fully charged the

device should last 3 to 4 days of constant use.

To charge using the battery charger supplied, plug the charger into the

top socket on the left side of the docking station. (See item 10 Page 5)

Turn on the charger at the electric socket.

WARNING: The Drip Monitor will not run while

charging. Do not plug the charger into the docking

station while the Drip Monitor is in use.

The Drip Monitor will alarm when the battery level becomes low and

requires charging. The alarm is a tone pulse every 30 seconds.

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Page 5

Getting to know the Indicators, Buttons and Connections

Red-Eye™ Display Unit

•

†

ƒ

‚

„

•

‚

ƒ

„

‡

…

†

„ ⑦

Display screen

Top row keys - function keys

Arrow keys to change values

Green (OK) indicator

Red alarm indicator

Power On/Off button

Giving Set Chamber Clip

…

Docking station

⑧ Sensor-lead socket

⑧

⑨ Pole clamp bracket

⑩ Charger socket

⑪ Bag light alarm socket

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⑨

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⑩

⑪

Page 6

What the Symbols on the Device Mean.

An electrical safety classification in the international

safety standard for medical electrical equipment, type

BF. If the equipment is used as intended there is no

risk of a serious electric shock, but it is not suitable

for direct connection to the heart.

Refer to the accompanying instructions on how to use

the equipment. The instructions are all in this manual.

The CE mark demonstrates that the Drip Monitor

conforms to the requirements in the European Council

Directive 93/42/EEC concerning medical devices. The

number 0123 identifies the Notified Body under

which the Quality Systems operated within Zimed Ltd

are assessed.

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Page 7

Setting Up The Drip Monitor.

The Drip Monitor is a battery operated device. It must be

charged initially, via the mains battery charger, for 5 hours

to ensure maximum operation of the internal battery. (See

Charging the Batteries page 5) The time and date must be

set before using the device. Once charged, the internal

battery will operate for up to 72 hours. Only use the RedEye™ charger supplied.

1. Attach docking

station to drip

stand using the

pole clamp. Use

the thumbscrew to

secure.

2. Clip display unit

onto the docking

station.

3. Insert sensor clip lead into

socket on the

docking station.

•

4. Attach sensor clip

to giving set

chamber and clip

to side.

ƒ

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‚

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Setting The Drip Monitor.

To Switch “ON” Press the Blue Button

SOLUTION, BLOOD, OR MENU.

v 20 DROPS =1mL SOLUTION,

15 DROPS =1mL BLOOD, OPTIONS =

Parameters of the Monitor

This is the first screen that appears when the

Monitor is turned on.

You must select either “Solution” or “Blood” to

set a desired flow rate:

To change any parameters of the monitor select

the “Menu” button. This will allow you to change

different setting in the monitor.

“First Screen”

GIVING SET

SELECT

SOLUTION BLOOD

MENU

Press “MENU” to change any of the settings on

these screens (See page 9)

TO SET YOUR DESIRED FLOW

RATE IN ml per hour

YOU SET THE FLOW RATE USING

THE ROLLER CLAMP AS NORMAL THIS SCREEN DISPLAYS THE FLOW

RATE IN ml per hour.

ONCE THE SCREEN DISPLAYS

YOUR DESIRED RATE PRESS

“START”. THE VALUE ON THIS

SCREEN IS SAVED AS YOUR “SET

RATE”. PRESS THE “OFF” BUTTON

IF YOU NEED TO RETURN TO THE

START.

Pressing the New infusion button resets

the V.T.B.I (Volume to be infused);

pressing the cont infusion button

continues the V.T.B.I counter.

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SET ROLLER CLAMP

0000 ml / h

OFF

START

Page 9

Parameters of the Monitor.

1-TOTAL VOLUME TO BE INFUSED.

v Required if giving multiple bags or small amounts less than one full bag

v If only giving full single bags ignore

v To change this screen press: the “menu” button once.

“MENU”

v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button

to move the flashing digit to the next digit along.

2-ALARM RANGE

v See Graph below, show’s the amount the I-V can deviate before an alarm is given

v To change this screen press: the “menu” button once and then the “next”

button once

“MENU”-“NEXT”

v To change use the up and down arrows (Min value 10%-Max 90%)

3-ALARM DELAY

v Equals the length of time the “Actual Rate” is out of range before it will alarm

v Once set to a value this generally does not need to be changed.

v To change this screen press:: the “menu” button once and then the “next”

button twice

“MENU”-“NEXT” “NEXT”

v To change use the up and down arrows (Min value 10 seconds - Max 90seconds)

4-PATIENT IDENTIFICATION.

v Required if Data logging, if not logging then ignore

v To change this screen to the correct Patient Id, press the “menu” button from the first screen that

appears when the monitor is turned ON, then the “NEXT” button 3 times

“MENU” “NEXT””NEXT””NEXT””

v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button

to move the flashing digit to the next digit along.

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Page 10

Monitor is now “SET”

THIS SCREEN DISPLAYS THE “SET

RATE” (TOP OF SCREEN) AND THE

“ACTUAL RATE” (CENTRE OF SCREEN)

THE CURRENT I-V RATE

IF THE “ACTUAL RATE” (CENTRE OF

SCREEN) FALLS OUTSIDE ITS ALARM

RANGE THE BLACK BELL SYMBOL WILL

BE SHOWN.

SET RATE 000

0000

ml/h

MUTE HOME VOL

IF THE BELL SHOWS FOR LONGER THAN

THE SET ALARM DELAY TIME THE DRIP

MONITOR WILL ALARM (See Alarms

below)

“Mute”

TO “MUTE” THE ALARM PRESS THE

BLUE KEY. THE ALARM WILL BE MUTED

FOR 3 MINUTES TO GIVE TIME FOR ANY

CHANGES TO BE MADE ALLOWING THE

“ACTUAL RATE”” TO BE BROUGHT TO

WITHIN RANGE OF THE “SET RATE”.

DISPLAYS THE TOTAL

VOLUME INFUSED, THIS

SCREEN RETURNS TO

THE PREVIOUS SCREEN

AUTOMATICALY

“OFF”

TO SWITCH OFF THE DRIP MONITOR –

PRESS THE “HOME” BUTTON THEN THE

WORD OFF APPEARS ON THE LEFT OF THE

SCREEN. PRESS AND HOLD UNTIL THE

SCREEN TURNS OFF.

Alarms

The main alarm is an audible tone pulsed every 10 seconds. If the flow

rate deviates to outside the alarm range, preset by the operator, (See

“Parameters of the Drip Monitor”), the green light on the front of the

monitor will go out and the red light will illuminate. The display also

reverses from mainly white to mainly black.

For night time use the audible alarm can be turned off and the bag light

plugged in to the docking station (see Getting To Know the Indicators,

Buttons and Connections on page 5). The bag light is clipped on to the

corner tab of the bags of fluid.

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Page 11

Device Set Contents / Accessories.

The Red Eye Intravenous Drip Monitor Device Set comprises of:

Quantity

Description

Part Number

1

Display Unit

Z-3-009/B

1

Docking Station

Z-3-008/A

1

Sensor Lead

Z-6-001/C

1

Mains power charger

Z-3-014/B

1

Operating manual

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Bag light

Z-7-001/A

Optional Extras

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PC software

Part Number on Request

PC Data download lead

Part Number on Request

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3: Care and Maintenance.

When used as described in these instructions the Monitor does not require

any routine maintenance apart from the occasional cleaning.

It is recommended that the performance of the monitor is checked annually.

If the monitor is damaged in any way the performance must always be

checked before it is used again. See Servicing on page 13 for further

information.

Cleaning.

The outside surfaces can be cleaned by wiping with a soft cloth either

dampened with a solution of mild detergent or disinfectant, in water.

Cleaning with organic solvents, e.g. surgical spirit, or abrasive cleaners, may

damage some of the plastic parts.

WARNING:

Risk of change in device performance.

Never dip or immerse the Drip Monitor in any

liquid or try to sterilize it with steam or gas. It is

not completely sealed.

Storage.

If you are going to store the Drip Monitor for some time, isolate the battery by

inserting a paper clip type probe into the hole on the back of the display unit

and press the switch in the hole to turn it off. Store in warm dry place.

When you are ready to start to use the Drip Monitor, repeat the same

process as above and then turn on the Drip Monitor to check the status of

the battery, charge if necessary before use.

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Servicing.

Either the Zi-Medical service department must repair the Drip Monitor, or one

of its appointed representatives, or an appropriately trained technician who

has access to the correct technical manuals, service bulletins and approved

replacement parts.

WARNING:

Risk of change in device performance. Always use the

appropriate parts and procedures for repair and

testing as advised by Zi-Medical and published in its

literature.

For after-sales service or advice on how to use the Monitor you can contact

customer services either by telephone, email or by letter, the details are to

be found on back-cover of this manual.

Please have the serial number to hand when you call, which is found on the

label on the reverse of all the units: Display, Docking, and Charger units.

Disposal.

When the time comes to dispose of the Monitor, accessories or packaging

do so in the best way to minimise any negative impact on the environment.

You may be able to use special recycling or disposal schemes. To find out

about these contact your local waste disposal service. Separate any parts of

the equipment where arrangements can be made for their recovery, either by

recycling or energy recovery.

Important: existing national or local regulations concerning waste disposal

must take precedence over the above advice.

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What’s the problem?

If the Drip Monitor does not perform as expected, if it is dropped, gets wet or

is damaged in any way, then remove it from use immediately. Label it clearly

as quarantined and preferably take it out of the working area, to ensure it

cannot be used accidentally until it has been checked.

The Drip Monitor must be carefully inspected for damage inside and its

performance checked to the specification. A properly trained technician must

complete these tests.

WARNING:

Risk of change in device performance. If the Drip Monitor gets wet

do not just dry the outside and then continue to use - liquid may

be inside and could have caused damage. Follow the advice

given above

Helpful Hints.

1 Re charge overnight.

2 When clamped on drip stand, try to angle back to enable clear

view of screen.

3 Fit drip sensor clip about 1 to 2mm from the top of the giving set.

4 Ensure that the giving set is vertical.

5 If not vertical, rotate the sensor clip until drip detection is made in

the giving set screen.

Monitor stopped working.

A If the Sensor Fault message appears on starting the Drip Monitor check

the following:

Is the sensor lead connected?/Plugged in to the socket correctly?

Is the sensor too low on the giving set and the beam below the water

level?

Is the sensor too high and the beam being broken by the giving set

pipette?

Is there condensation or any splashes in the giving set chamber?

Is the Drip Monitor in very bright daylight?

Is the battery low in the Drip Monitor?

B If the green light is not flashing when using roller clamp screen, see points

2 to 4 above.

C If the green light ceases to “blink” when the drip passes the sensor,

ensure the clip position is such that the beam is broken by the drip.

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4: A Guide to Suitable Applications.

The Red-Eye™ IV Drip Monitor is intended to be used in combination with an

intravenous drip, i.e. .an administration set and an IV fluid bag.

Intravenous drips are used to deliver blood, blood products, antibiotics,

and saline or dextrose based products.

The Drip Monitor functions by calculating flow rate (ml per hour), via a fibre

optic cable connected to a flexi-clip fitted to the administration set of the IV

apparatus.

There are two broad categories of administration sets, which the Drip Monitor

is compatible for use with:

v Blood Administration sets: - calibrated to deliver 15 drops per ml of

blood.

v Solution Administration sets: - calibrated to deliver 20 drops per ml of

H2O. These sets are suitable for all saline/dextrose-based products.

MINIMUM DIAMETER:

17 mm

of administration set

MAXIMUM DIAMETER:

24 mm

of administration set

MINIMUM DIAMETER:

12 mm

of drip stand

MAXIMUM DIAMETER:

30 mm

of drip stand

Please refer to the individual manufacturer of administration sets for

advice regarding administration of drugs / fluids not easily categorised

into blood or saline type fluid.

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5: Technical and Performance Specification.

Administration set

15 or 20 drops/ml

Measurement range

10 to 1000 ml/hour

Alarm range

10 to 90% in steps of 10%

Alarm delay

10 seconds to 90 seconds in steps of 10 seconds

Mute delay

3 minutes

Pre-set volume to infuse

0 to 9999 ml in steps of 1 ml

Total measurement

9999 ml manually re-set

Accuracy:

±20% (H2O at room temperature)

Operating time

At least 72 hours continuous from full charge

Recharge time

5 hours maximum

Time

Displayed continually when in use

Date and time

Recorded at start of administration

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6: Addendum, Electromagnetic Compatability

This addendum to the Red Eye ™ User Manual provides information required by EN60601-1-2:2001. It

describes the Standards to which the Red Eye ™ was tested and approved, the minimum test level

identified in the Standard, and general guidance on management of the EMC environment in which the Red

Eye ™ may be safely used.

Precautions should be taken to avoid exposing the Red Eye ™ to powerful sources of electromagnetic

radiation such as MRI (magnetic resonance imaging) and ESU (electrosurgical equipment).

Note also that portable and mobile communications equipment such as cell phones can adversely affect

medical electrical equipment.

The Red Eye ™ drip monitor is intended to be used in conjunction with other equipment, forming a “system”.

Correct operation of all elements of the “system” must be verified before use.

Table 1: Guidance and Manufacturers Declaration - Electromagnetic Emissions

The drip monitor is intended for use in the electromagnetic environment specified below. The customer or

the user of the drip monitor should assure that it is used in such an environment.

Emission Test

Compliance

Electromagnetic environment - Guidance

RF emissions

CISPR 11

Group 1

The drip monitor uses RF energy only for its internal function.

Therefore, its emissions are very low and are not likely to

cause any interference in nearby electronic equipment

RF emissions

CISPR 11

Class A

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations

/ flicker emissions

IEC 61000-3-3

Not applicable

The drip monitor is suitable for use in all establishments

other than domestic and those connected to the public low

voltage power supply network that supplies buildings used

for domestic purposes.

Table 2: Guidance and Manufacturers Declaration - Electromagnetic Immunity

The drip monitor is intended for use in the electromagnetic environment specified below. The customer or

the user of the drip monitor should assure that it is used in such an environment.

Immunity Test

Electrostatic

discharge (ESD)

IEC 61000-4-2

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IEC 60601

Test level

Compliance

level

+/- 6kV contact

+/- 6kV contact

+// 8kV air

+/- 8kV air

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Electromagnetic environment Guidance

Floors should be wood, concrete or

ceramic tile. If the floors are covered

with synthetic material, the relative

humidity should be at least 30%.

The drip monitor rate display may clear

to zero at levels above 8kV air. Do not

touch the connector pins directly. The

connector is marked with the symbol for

ESD sensitivity (ref. IEC 60417-5134)

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Electrical fast

transient burst

IEC 61000-4-4

+/- 2kV for power

supply lines

+/- 1kV for input/

output lines

Not applicable

Surge

IEC 6100-4-5

+/- 1kV differential

mode

+/- 2kV common

mode

Not applicable

<5% UT (>95% dip

in UT) for 0.5 cycle

40% UT (60% dip

in UT) for 5 cycles

70% UT (30% dip

in UT) for 25 cycles

<5% UT (>95% dip

in UT) for 5 sec

Not applicable

3 A/m

3 A/m

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

Power frequency

(50/60Hz) magnetic

field

IEC 61000-4-8

Not applicable

Not applicable

Not applicable

Not applicable

Mains power quality should be that of a

typical commercial or hospital

environment.

The drip monitor is not functional while

mains power is connected for charging

the battery.

Mains power quality should be that of a

typical commercial or hospital

environment.

The drip monitor is not functional while

mains power is connected for charging

the battery.

Mains power quality should be that of a

typical commercial or hospital

environment.

The drip monitor is not functional while

mains power is connected for charging

the battery.

Not applicable

Power frequency magnetic fields should

be at levels characteristic of a typical

location in a typical commercial or

hospital environment.

Table 3: Guidance and Manufacturers Declaration - Electromagnetic Immunity - for

equipment and systems that are Life-Supporting

The drip monitor is intended for use in the electromagnetic environment specified below. The customer

or the user of the drip monitor should assure that it is used in such an environment.

Immunity

Test

IEC 60601

Test level

Compliance

level

Electromagnetic environment Guidance

Portable and mobile RF communications

equipment should be used no closer to any

part of the drip monitor, including cables,

than the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance:

Conducted RF

IEC 61000-4-6

3 Vrms

150kHz to 80MHz

outside ISM bands

Not applicable,

ref. EN60601-12:2001 clause

36.202.6 a)5

d=1.17√P

10 Vrms

150kHz to 80MHz

in ISM bands a

Not applicable,

ref. EN60601-12:2001 clause

36.202.6 a)5

d=4√P

a

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Radiated RF

IEC 61000-4-3

10 V/m

80MHZ to 2.5GHz

3 V/m (3)

d=4√P 80 MHz to 800 MHz

d=7.67√P 800 MHz to 2.5 GHz

where P is the maximum output power

rating of the transmitter in watts (W)

according to the transmitter manufacturer

and d is the recommended separation

distance in metres (m) b.

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site

c

survey, should be less than the

d

compliance level in each frequency range .

Interference may occur in the vicinity of

equipment marked with the following

symbol:

10 V/m (3)

The drip monitor may not operate correctly

above 3 V/m. (3)

Note 1

At 80 MHz and 800 MHz the higher frequency range applies

Note 2

These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

Note 3

The drip monitor was designed to meet EN60601-1-2:1993

The ISM (industrial, scientific and medical) bands between 150kHz and 80 MHz are

6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz,

and 40.66 MHz to 40.7 MHz.

a

The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and

in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood

that mobile/portable communications equipment could cause interference if it is

inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is

used in calculating the recommended separation distance for transmitters in these

frequency ranges.

b

Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM

radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.

To assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should be considered. If the measured field strength in

the location in which the drip monitor is used exceeds the applicable RF compliance

level above, the drip monitor should be observed to verify normal operation. If

abnormal operation is observed, additional measures may be necessary, such as

reorienting or relocating the drip monitor.

c

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3

V/m.

d

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Table 4: Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the Drip Monitor - for Life Supporting

Equipment and Systems

The drip monitor is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the drip monitor can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the drip monitor as recommended below, according to

the maximum output power of the communications equipment.

Separation Distance according to Frequency of Transmitter (m)

Rated maximum

output power of

Transmitter (W)

150 kHz to 80

MHz outside ISM

bands

d=1.17√P

150 kHz to 80

MHz in ISM bands

d=4√P

80 MHz to 800

MHz

d=4√P

800 MHz to 2.5

GHz

d=4√P

0.01

0.12

0.4

0.4

0.77

0.1

0.37

1.26

1.26

2.42

1

1.17

4

4

7.67

10

3.7

12.65

12.65

24.24

100

11.7

40

40

76.67

For transmitters rated at a maximum power output not listed above, the recommended separation

distance d in metres (m) can be estimated using the equation applicable to the frequency of the

transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to

the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance of the higher frequency range applies.

Note 2: The ISM (industrial, scientific and medical) bands between 150kHz and 80 MHz are 6.765 MHz

to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz, and 40.66 MHz to

40.7 MHz.

Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for

transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency

range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications

equipment could cause interference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

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