印刷使用色：２色 作成倍率：100％ 寸法（W×H）

：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（表４ / 表１）

TOP INFUSION PUMP

TOP-3300
OPERATION GUIDE
Please read through this “Operation Guide” and follow the “Precautions for Use”
and “Directions for Use” before using the TOP-3300 Infusion Pump.

TOP INFUSION PUMP

TOP-3300 VOL.
LIMIT
TOTAL
VOL.
mL
BATTERY INDIC
ATOR

SET UP

RATE
CHARGE
ON
OFF

START

CLEAR
STOP
SELECT PURGE
SE T
SYSTEM
ERROR

TOP
INFU
TOP SION

Manufacturer : -330
PUM

0
P

19-10 Senjunakai-cho, Adachi-ku, Tokyo 120-0035, Japan

European Regulatory Representative :
MPS Medical Product Service GmbH
Borngasse 20, 35619 Braunfels, Germany
Original instructions (P33B1A80B0, P33B1A80B1, P33B1A80B2, P33B1A80B3)-8
TOP Corporation. ENGLISH. WC. DP. 081110-1000 Printed in Japan 2011 TOKYO, JAPAN

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P2 / P3）

Contents
Handling of Product Selection of Settings and Maintenance
Precautions for Use 4∼9 Selection of settings 38, 39
Purpose / Outline of the Product  10 How to select set values  38
Purpose of the product 10 List of settings 39
Outline 10 Maintenance 40∼43
Exterior Features 11∼15 Cleaning, Sterilization 40
Preparation before use 16∼17 Environment-friendly disposal, recycling 40
Checking accessories 16 Periodic maintenance 41
Default settings at shipment 16 Maintaining battery performance 42
Installation of the system 17 Removing / installing the internal battery 43
Directions for use 18∼31
Preparation before use • Commencement-of-work check 18∼23
Operation flowchart 24
Technical References
Suspending the infusion and changing the infusion rate / volume limit 25
Purging 25 Specifications 44∼53
Clearing the total volume 26 Specifications 44∼45
Terminating the infusion 26 Options 46
Replacing IV sets 26 Technical Data 47∼50
Operation from the internal battery 27 Maximum delay for activation of occlusion alarm
Adjusting the buzzer volume 28 and bolus volume 50
Operation from DC power supply 28 Infusion Accuracy Information 51∼53
Using the equipotential terminal 29 Recommended Administration IV sets 54
Using the pole clamp 29 Glossary 55
Using the nurse call 29 Symbols 55
Computer integrated communication (optional) 30
Changing the IV set 31
Troubleshooting 32∼37

2 3

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P4 / P5）

Precautions for Use

Warning <Direction for Use>
•Avoid using the system in the control areas for radiological equipment and MRI
<Direction for use>
and in a HBO room.
•Check the infusion status (drip status, remaining infusion fluid amount) and the
Do not use the system for placing an infusion line in a HBO room.
patient’s infusion site.
[This system is not designed for use in such environments. Use of the system in
Also check the aforementioned items periodically during infusion.
such environments may cause improper operation, damage or explosion of the
[The system system.]
1. Does not operate on the principle of direct measurement for infusion
accuracy. •Do not change the height of the device in relation to the level of the patient’s
2. Does not detect leaks from infusion line disengagement and/or filter damage. heart during infusion.
3. Does not have an alarm feature for extra vascular infusion when the cannula [Otherwise, a sudden positive or negative pressure causing bolus or reflux may
is not in the vein.] occur.]
•Ensure that the tube is attached properly to the finger unit, the tube guide and •Avoid using the system in a flammable environment.
each detection unit when the tube is attached. [Fire or explosion may be caused.]
[If the tube is not attached properly, there is a possibility that it is not possible •Avoid using the system in parallel with gravity infusion.
for normal infusion such as excessive or deficient dosage, and non-dosage of [In such a case, proper infusion may not be performed or the alarm may not
the infusion fluid.] operate since air may be generated at the fitting of the injection line in the
•If occlusion occurs due to kinked tubes and clotted filters or cannula in the downstream of the pump or occlusion may not be detected in the downstream
infusion line, take proper action such as clamping the infusion line with a roller of the fitting of injection line.]
clamp. •Do not use the IV sets other than the “Recommended Administration IV Sets”
[If such a case occurs, the internal pressure is high in the infusion line. when infusing the drug that has a short half-life and/or small effective range of
Removing the cause of the occlusion in this state causes a “Bolus injection” concentration, such as when administering liquid at a low speed to a neonate.
(excessive dosage of IV fluids).] [Otherwise, the initial flow rate may decrease and a temporary excessive or
•Arrange the roller clamp in the downstream of the pump. deficient dosage may occur because the short-term infusion accuracy does not
[This system does not have an upstream occlusion detection feature. If a roller stabilize.]
clamp is closed upstream, non-dosage of infusion fluid will not be detected.] •Pay extra attention to kinks of the infusion line when it is used for low-infusion.
•Avoid using devices that generate a high-frequency such as cellular phones, [The smaller the set infusion rate becomes, the longer it takes from the
wireless phones, electrotomes, and defibrillators in close proximity to the occurrence of occlusion to its detection, which may suspend the infusion for a
system. long period of time.]
Use a separate power supply from such devices for the system and ensure that
it is grounded. Caution
[Otherwise the system may malfunction.] •Only skilled personnel should use the system.
•Stop using the system immediately if the system suffers any impact due to •Turn on the power before use, confirm the self-diagnosis completion, and check
being dropped onto the floor or the tipping over of the drip infusion stand. whether indicators illuminate.
[Even if the system appears undamaged, internal damage is possible.
•Never place the system within the reach of the patient.
Inspection of the system is necessary.]
•Always operate the system with the internal battery installed.
[Otherwise, the system may stop without issuing an alarm when the external
Contraindication and Prohibitions power is interrupted due to a power failure or a short circuit, causing an unsafe
<Medical devices used with the system> condition.]
•Avoid using the system with other than specified the IV sets. •If earth grounding is poor, use an internal battery.
[If the system is used with other than specified the IV sets, the infusion accuracy Before internal battery operation, check the battery to ensure that sufficient
and the alarm feature cannot be guaranteed; and in addition, may lead to power is available. Recharge, if required.
medical accidents. Refer to “Recommended Administration IV Sets” on page 54.] •When using AC power, always use the attached AC power cable and ensure it is
properly grounded.
4 5

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P6 / P7）

Precautions for Use

•When the system is used for the first time after purchase or after being unused •Check that the cannula in the vein is secured before starting the infusion.
for a prolonged period, connect the system to the AC power supply and charge
the system (for more than 24 hours) with the power OFF. •Avoid using the system with an alarm sounding.
[If the system is not charged sufficiently, it may not be operated with the •After every 24 hours of infusion, replace the IV set or move the position of the IV
internal battery in case of electric power failure.] set tube by more than 15cm, and attach in a new portion.
•Ensure the infusion pump is firmly affixed to the infusion stand. Also check the [When carrying out infusion for a long period of time at the same point, the
stability of the infusion stand. accuracy is unwarrantable.]
•During infusion, secure the device using Pole Clamp or suchlike to avoid •When detaching the IV set from the system, first close the roller clamp of the IV
changing the device’s height in relation to the height of the infusion site. set and then detaches it.
•Place the system within 130cm above or below the patient’s heart. [This is to prevent possible excessive dosage caused by free flow.]
•If the infusion fluid drops onto an AC or DC inlet, short circuit may occur. •To stop the system, turn the power off by pressing and holding the “power key”
Pay attention to the installation place and check that the connecting parts are for at least 2 seconds.
dry when connecting the connector. Even if the power cable is disconnected with the power on, the system does not
•Always perform an inspection before use. stop operation because of the power supplied from the internal battery.
If any abnormality is found, stop using the system immediately and contact the •The self-diagnosis feature in this system will stop device operation and emit an
dealer you purchased product from.
alarm on detecting the internal fault.
•During extended infusion fluid containing nutrient for a neonate, bacteria may The detection period is approximately 10 seconds.
multiply the infusion line.
Determine the administration plan to minimize the duration of each infusion (for •The maximum total volume of infusion fluid under the single fault condition is
example, divide the volume a few times). less than 2.7mL.
•Wait until the temperature of the infusion fluid reaches room temperature. •If the alarm sounds while using the system, refer to the “Trouble Shooting” on
[If the infusion is used while it is cold, air bubbles may be generated due to page 32.
vaporization of dissolved air, leading to the air-in-line alarm.]
•The drop sensor detects drops and does not measure the infusion rate.
•If infusion fluids that has different surface tension, specific gravity and viscosity If the infusion fluid in the drip chamber drips continuously, flow rate error can
than those of saline (such as an infusion fluids mixed with a surface-active not be detected.
agent) is used, the infusion may not be performed with the accuracy given in the
specifications. •Never reuse or resterilize the IV set.
Dispose of any used IV set in a safe and environmentally appropriate manner.
•To secure the connection with the infusion circuit, use of the lock type products
is recommended. •Use a soft damp cloth with warm water to wipe infusion fluids off the exterior
surface.
•Check that the operation panel at power ON shows the target IV set.
•Avoid direct sunlight, abnormally high temperatures or humidity.
•Avoid mounting the IV set upside down.
[Blood in the vein may backflow into the infusion line.] •Avoid installing the system near a chemical storage area or where gas is
produced.
•If the tube is not attached straight, the door may be hard to close. If the door is
hard to close, do not force the door, but check the position of the tube. •Avoid autoclaving the system or exposing it to chemicals.
[If closed forcibly, there is danger to evoking the damage and fluid leak of the
•When starting the system that has not been used for a prolonged period of time
system and the tube.]
(more than one month) or if the internal battery power is significantly low,
•Before venipuncture or after exchange the IV set, prime the system. several minutes may be required before the internal battery alarm is reset after
the system power supply has been connected.
•Use your fingers to operate keys.
If the alarm indicator is still on five minutes after the power supply has been
[Using tools with a sharp tip may damage the panel surface.]
connected, the internal battery must be considered faulty. Please contact the
•Check that the setting of infusion (infusion rate and volume limit) has been done service department.
correctly before start infusion.

6 7

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P8 / P9）

Precautions for Use

•If the internal battery deteriorates with age, the operation time indicated by the Interaction
[Battery Indicator] becomes shorter.
<Caution for co-administration>
To check deterioration of the internal battery and maintain display accuracy of
•Analog and digital devices (external DC power supplies and communications
the [Battery Indicator], charge / discharge the internal battery once a month.
devices) connected to the system should conform to the IEC standards. (The
•If another infusion system or other accessories are connected to the system’s standard for medical electrical devices, IEC 60601-1-1; the standard for
infusion line for parallel infusion, the resulting operation may not conform to the information technology devices, IEC 60950.)
system specifications (For example. VDE 0753-5 “Application rules for parallel
•Pay attention to safety and check the specifications of the medical monitor
infusion - Conceivable ways of use”).
and/or office automation equipment such as PCs when connecting them to the
•Do not disassemble or modify the system. system. Any connection cables used shall comply with EMI requirements.
[We are not responsible for the system if it has been disassembled, modified, or
•When the system is used near an electrotome : A medical electrotome is a piece
used for other purposes.]
of surgical equipment for incision and coagulation of living organisms using
•In the system does not operate as specified in this Operation Guide and the high-frequency current. If the system is used near an electrotome, malfunction
cause is unclear, stop operation of the device and report the circumstances may occur due to high-frequency noise. When the electrotome is used with the
when the fault occurred (including IV set used, infusion rate, serial number, type system, check the following before use.
of infusion fluid used) to the dealer you purchased the product from.
(1) High-frequency noise generated differs according to the electrotome type.
•Use the system according to the instructions in this Operation Guide. Avoid using the older types (tube gap type) because they generate higher
[Users are responsible for any results induced by neglecting the precautions or noise.
operations procedures in this document.] (2) Set the system apart from the electrotome cables (electrotome holder,
electrotome cable and anti-pole plate cable) and the electrotome itself by
<Selection of infusion therapy> more than 25cm.
•When infusing a drug that has a short half-life and that has a small effective
(3) Supply power to the electrotome and the system from different outlets and
range of concentration, such as when administering liquid at a low infusion rate
ensure that they are properly grounded.
to a neonate, we strongly recommend using a TOP IV set from TOP Corporation
(for infusion pump) H series. •Only persons who can ensure conformity to IEC 60601-1-1 standard should
connect the system to an external DC power supply or a communications
•Refer to “Specifications” on page 44 for information on how identify therapies
device.
that may not be suitable for use with the system.
•Use the specified power cable and external communications cable.
<Cautions for infusion rate setting> [Otherwise, electromagnetic noise may be increased or the
•For infusion rate setting, refer to the “Start-up curves” and “Trumpet curves” on anti-electromagnetic noise capability of the system may be degraded.]
page 52-53, and take the type of drug into account.
•The device should not be used adjacent to or stacked with other device.
•When you wish to perform high-precision infusion with a maximum volume of If adjacent or stacked use is necessary, the device should be observed to verify
10mL or if drug with a very short half-life is used for infusion, you should normal operation in the configuration in which it will be used.
carefully determine the administration plan to improve effectiveness of the
treatment, taking the characteristics of the drug used into consideration. •Be aware that the system is more sensitive to electrotomes, cellular phones,
(e.g.) ・When a drug such as catecholamine has a short half-life for the wireless phones, and defibrillators when the communications feature is in use.
concentration. Check periodically to ensure that the system is operating properly.
・When administration of a small amount of drug is sufficient for a
•To secure the safety as a system, check that the system conforms to
premature baby or neonate.
IEC60601-1-1:2000 when connecting it to other medical equipment and/or
medical monitor.

8 9

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P10 / P11）

Purpose / Outline of the Product Exterior Features

Purpose of the product Main body / option
The Infusion pump TOP-3300 from TOP Corporation is an electric pump
device which administers and controls the infusion fluid in accordance with Operation indicator Alarm indicator Handle
preset procedures and thus provides a wide range of applications for infusion The green light will flash The red light will flash if Used for carrying the
therapy. while infusion is normally an alarm occurs. TOP-3300.
in progress.

Outline Case
Protects TOP-3300 from
•General-purpose IV sets of 15drops/mL, 19drops/mL, 20drops/mL, or Operation panel fluid drops or impact.
60drops/mL can be used. Used for entering settings
required for TOP-3300
• A wide range of infusion rates can be supported (max. 999.0mL/h) operation. For details, VOL.
LIMIT BATTERY INDIC

(If a TOP-H series dedicated IV set is used). refer to page 15. TOTAL
VOL.
mL
ATOR

SET UP

RATE

• A safety mechanism is provided which keeps the power on in case the CHARGE
ON
OFF

power key OFF

ON
is inadvertently pressed during infusion. Door START

Secures the tube of the CLEAR

• A safety design prevents air bubbles from entering the patient’s vein during IV set to be attached. SELECT PURGE
STOP
SE T
infusion (3 steps). SYSTEM
ERROR

• A storage function for infusion rate, total volume and volume limit data can
be selected before power off.
• Presence/absence of the Wait tone and key operation tone can be selected.
• Occlusion detection pressure can be selected.
(4 steps : if TOP-H series dedicated IV set is used)
(2 steps : if general-purpose IV set is used)
• An estimate of the recharge status and the remaining power of the internal
Pump fingers
battery will be displayed by a three-step indicator.
Press the tube to deliver
• Three types of power supply are available --- AC supply, external DC the infusion fluid.
supply, internal battery.
• The optional specification model supports a computer-integrated Door handle Air-in-line sensor
communication feature (RS-232C). Latches the door to main Detects air in the infusion
body. line.

Tube retainer Tube clamp Occlusion sensor

Presses the tube of the Clamp the tube to block Checks the pressure in
IV set at a constant the flow so that infusion the infusion line.
pressure. fluid will not be delivered
excessively when the
door is opened.

10 11

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P12 / P13）

Exterior Features
Rear Bottom

Nurse call / Drop sensor holder Threaded hole

communication Holds the drop sensor Used to attach TOP-3300
connector when not in use. to pole clamp or
For nurse call cable. dedicated stand.
TOP-3300 with
communication interface DC inlet
outputs status on
external medical monitor For optional DC power
via RS-232C interface. cable.

Drop sensor
connector
Accepts drop sensor.

Fuse
Fuse for AC power supply.
Rating : T1A × 2 AC inlet
For AC power cable.

Equipotential terminal
Connects TOP-3300 and Ni-Cd battery
equipotential bus of the
Type : BP-53
facility.
Rating : DC12V 700mAh

Volume adjustment
Rotating this control will
adjust volume of
TOP-3300 buzzer.

12 13

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P14 / P15）

Exterior Features
Accessories Operation panel
Internal battery operation indicator Battery charge indicator
Illuminates while system operates on Illuminate while internal battery is
internal battery. Flashes when the battery being recharged.
power is low.
DC power supply operation indicator AC / DC power supply indicator
Illuminates when system operates on Illuminates while connected to the
DC power supply. AC / DC power supply.
Volume limit display lamp
Illuminates while volume limit is Indicated.
Battery indicator
Total volume display lamp Indicates the residual internal
Illuminates while total volume is Indicated. battery power in three steps.
Set up lamp
Drop sensor AC power cable Illuminates when
Checks for abnormal Used when operating infusion rate is set. VOL.
LIMIT BATTERY INDICATOR
drops in drip chamber. TOP-3300 from AC power TOTAL
VOL.
and for recharging. Total volume / mL
Volume limit display SET UP
Displays current total ON
RATE Power key
volume / volume limit mL
CHARGE
OFF
／h Turns power
and various messages.
supply ON / OFF.
Infusion rate display
START Start key
Options Displays infusion rate
set value. Starts infusion.

CLEAR STOP Stop / Silence key

Up / Down key Stops infusion.
Used to set infusion PURGE If this key is
rate, volume limit, SELECT SET SYSTEM ERROR pressed while an
and IV set used. alarm sounds, the
buzzer is silenced.

System error alarm indicator

Select key Indicates internal errors of
Switches between display of TOP-3300.
infusion rate set value and
volume limit set value. Drop indicator
Pole clamp DC power cable Indicates drop status of fluid in the
A fixture base for simple Used when operating drip chamber.
attachment of TOP-3300 TOP-3300 from an
Set key
Once you have confirmed that the Clear key
to pole. external DC power
IV set attached is identical with that If this key is held down for two
supply or for recharging. seconds or more, total volume will
For details, refer to
on the display and the IV set is properly
attached, press this key. be cleared to 0.
“Operation from DC
power supply” on page 28. Purge key
Performs infusion at maximum flow
rate of IV set attached while the
purge mode display is
generated.

14 15

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P16 / P17）

Preparation before use

Checking accessories Installation of the system
■ Take out the system out of the package box and check the accessories : Caution
•AC power cable × 1 •Use this system in approximately horizontal Infusion
pump
•Operation Guide × 1 position.
•Drop sensor × 1 •Place the system on a stable base or secure it Stand
to the pole clamp or dedicated stand.
•When using a pole clamp, align the attaching
Default setting at shipment screw with the threaded opening on the bottom
Pole clamp Screw

■ This system has been set as shown below. of the system, then turn the screw to secure the
TOP-H series dedicated IV set setting system.
Setting TOP-H series dedicated IV set used
20 drops / mL
Occlusion detection pressure setting
Setting Occlusion detection pressure
(TOP-H series dedicated IV set ) Medium (120kPa or less)
(General-purpose IV set) High (160kPa or less)

Infusion data storage setting

Setting Infusion rate Volume limit Total Volume
Not stored Not stored Not stored
Buzzer setting
Setting Wait tone Operation tone Warning tone
Enabled Enabled Enabled
Power supply warning setting
Setting Power supply switch warning Low battery warning
Continuous sound Continuous sound
Air-in-line detection level setting
Setting Air-in-line detection level
Medium (0.1mL/15minutes)

■ Users can select “TOP-H series dedicated IV set setting”, “Occlusion

detection pressure setting”, “Infusion data storage setting”, “Buzzer setting”,
“Power supply warning setting” and “Air-in-line detection level setting”
depending on the specific application.
For details, refer to “Selection of Settings” on page 38.

16 17

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P18 / P19）

Directions for use

5. Press the “Power key OFF
ON
” with the door open.
Preparation before use • Commencement-of-work check The buzzer should sound and the indicators illuminate in sequence.
The system automatically checks the features illustrated below :
1. Connect the attached AC power cable to the AC
inlet. (Fig.1) Sequence of display at power ON (e.g.: Default setting at shipment)

Caution
Infusion data Buzzer setting Power supply Air-in-line detection
•Secure the AC power cable until properly storage setting warning setting level setting
seated.
•Use the attached AC power cable only.
Occlusion detection Occlusion detection TOP-H series LED lighting
pressure setting pressure setting dedicated check by
2. Connect the drop sensor to the drop sensor Fig.1 (for TOP-H series (for general-purpose IV set setting visual inspection
connector. At that time, attach the drop sensor to dedicated IV set) IV set)

the drop sensor holder. (Fig.2)

Drop sensor
holder No error in self check IV set setting display
Caution
Secure the drop sensor connector until it
6. The pump finger rotates in the normal direction,
reaches the innermost part. BATTERY INDICATOR

and then reverses to check the operation of the Pi Pi

Pi……
drive mechanism and the rotation-detecting
3. Plug the AC power cable into a grounded power ON
sensor (housed inside and not visible externally). CHARGE
OFF
supply. The “AC / DC power supply indicator ”
Check that the pump finger moves smoothly.
and “Battery charge indicator CHARGE ” will illuminate
Fig.2 When the self-daignosis is complete, “ ” START
to indicate that the power supply is connected.
is displayed, settings of the IV set are displayed,
(Fig.3) STOP
and a buzzer sounds in short beeps to indicate
VOL.
LIMIT BATTERY INDICATOR
the wait state. (Fig. 4) Fig.4
4. Open the door. TOTAL
VOL.
mL
Check that the door hinge is not loose, that the SET UP
Caution
ON
tube retainer is firmly fixed to the door, and that RATE
mL
CHARGE
OFF
／h •Check that the “System error alarm indicator” illuminates temporarily
the clamping force of the tube clamp is strong
at power on. If the “System error alarm indicator” does not illuminate
enough. START
or remain on, a fault must be assumed. Contact the dealer you
Check that the door handle moves smoothly and
purchased the product from.
that the handle is free from looseness or rattle CLEAR STOP
•Perform the self-daignosis without an IV set attached. The motor will
when it is closed. Check that the pump finger, PURGE
Fig.3 turn and the finger will move to check the driving state of the system.
tube retainer, air-in-line sensor and occlusion
•The wait tone cannot be silenced by pressing the “Stop / Silence
detection sensor are clean.
key STOP ”.
•If the wait tone is set to OFF in the buzzer settings, the buzzer will
not sound (refer to “Selection of setting” on page 39).

18 19

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P20 / P21）

Directions for use

7. Prepare the IV set. Infusion Infusion 10. Select the IV set to be used.
bottle pump VOL.
LIMIT BATTERY INDICATOR

Suspend the infusion bag or infusion bottle from stand The “Volume limit / Total volume display” shows TOTAL
VOL.
mL

Drip SET UP

the infusion pump stand. Unpack the IV set and chamber a list of IV sets to be used. RATE
mL
／h
CHARGE
ON
OFF

move the IV set toward the end of the needle Use “Up / Down key ” to select the IV set START
Tube
while ensuring that the roller clamp will not to be used, then press the “Set key SET ” to CLEAR STOP

come into contact with the main body, then validate selection. (Fig.8) SELECT SET
PURGE
1
SYSTEM ERROR

close the roller clamp. After connecting the IV Roller

clamp Caution
set, perform pumping of the drip chamber to 2
store infusion fluid (the adequate volume of the Fig.5 After confirming that the type (drop) of IV set Fig.8
fluid is one third of the drip chamber volume). to be used is same as the type (drop)
Open the roller clamp, fill the tube with infusion of “Volume limit / Total volume display”
fluid, eliminate air bubbles, then close the roller shows, set by pressing the “Set key SET ”.
clamp. (Fig.5)
11. Set the infusion rate.
VOL.
BATTERY INDICATOR

8. Attach the tubing. Tube Pump fingers Prepare for setting the infusion rate. Check that LIMIT
TOTAL
VOL.
mL

Press the tube clamp lever at the bottom of the guide the “Setup lamp” is ON. If the indicator is OFF,
SET UP

RATE ON
CHARGE
mL OFF
／h

FLOW

FLOW

FLOW

FLOW

FLOW

FLOW
door and open the clamp until it locks with a press the “Select key SELECT ” to display the START

clicking sound. Set the tube straight, from the infusion rate set value. CLEAR STOP

finger at the uppermost area inside the door to Air- Then press the “Up / Down key ” to set SELECT SET
PURGE
SYSTEM ERROR
in-line
the air-in-line sensor, occlusion sensor and tube sensor the infusion rate. (Fig.9) The range of the
clamp in this order and close the door. (Fig.6) infusion rate will depend on the IV set used.
Occlusion Refer to the following table.
sensor Tube clamp Fig.9
Caution
Fig.6 IV set used Setting range
•Insert the tube fully into the air-in-line
TOP-H 1.0 - 999mL/h
sensor and occlusion sensor until it reaches
15 drops/mL 1.0 - 400mL/h
the innermost area.
19 drops/mL 1.0 - 380mL/h
•A loose tube or excessively stretched tube
20 drops/mL 1.0 - 360mL/h
may cause errors in the infusion rate.
60 drops/mL 1.0 - 150mL/h
Setting is enabled in 0.1mL/h steps up to 99.9mL/h.
9. Attach the drop sensor. For over 100mL/h, settings are made in 1mL/h steps.
Attach the drop sensor at the specified position
of the drip chamber. Then open the roller clamp. ＊ •Setting and changing the infusion rate can be
(Fig.7) performed only if the system is not operating.
•If the infusion is in progress, press the “Stop /
Caution Silence key STOP ” to place the system into the
•Set the drop sensor in the middle of the drip wait state, then perform setting.
nozzle end and the liquid surface.
•Set the drip chamber in vertical position so Fig.7
that drops of infusion fluid are detected
without fail.

20 21

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P22 / P23）

Directions for use

12. Set the volume limit. VOL.
14. Introduce the vein needle into the patient’s vein.
LIMIT BATTERY INDICATOR

Press the “Select key SELECT ” until the “Volume TOTAL

VOL.
mL
SET UP
(Fig.12) Vein needle
limit display lamp” illuminates to enter the RATE
mL
／h
CHARGE
ON
OFF

volume limit setting mode. Press the “Up / Down START

Caution
key ” to set the volume limit. (Fig.10) CLEAR STOP
Introduce the vein needle while system
SELECT SET
PURGE
2
SYSTEM ERROR
operation is suspended.
Caution
To perform infusion without setting the 1 15. Press the “Start key START ”.
volume limit, this procedure is not required. Fig.10 The wait tone will be silenced and the Fig.12
(If the volume limit is left unspecified, the “Operation indicator (green)” in the upper area of
display appears as “- - - -”.) the system will flash and the infusion will start.
During the infusion, the “Drop indicator” will VOL.
LIMIT
TOTAL
VOL.
BATTERY INDICATOR

13. Perform priming. flash with each drop of infusion fluid in the drip mL
SET UP
ON
VOL. RATE
BATTERY INDICATOR

Follow the procedure under “Purging” to prime chamber. (Fig.13)

LIMIT CHARGE
mL OFF
TOTAL
VOL.
／h
mL
SET UP

the infusion fluid until it reaches the end of the ／

RATE
mL
CHARGE
ON
OFF
START

needle. During purging, the priming volume will

h
Caution CLEAR STOP
START
PURGE

be added to the total volume on the “Volume CLEAR STOP

is displayed if the door has not been SELECT SET SYSTEM ERROR

limit / Total volume display” in units of 1mL. SELECT SET

PURGE
SYSTEM ERROR
opened / closed since power on with IV set
Fig.13
＊Procedure for purging attached.
While the infusion is in progress, press the “Stop Press
twice
/ Silence key STOP ” to place the system in the Fig.11
wait state. If the “Purge key ” is pressed
once, will appear in the infusion rate
display for one second.
Release the “Purge key ”, then press the “Purge key ” while
is displayed. Purging will be performed as long as the “Purge key ” is
held down. (Refer to “Purging” on page 25.)
To clear the priming volume, hold down the “Clear key CLEAR ” for two
seconds or more. (Refer to “Clearing the total volume” on page 26.) (Fig.11)

Caution
•Prime the IV set before introducing the needle into a patient’s vein.
•Priming is mandatory because otherwise the infusion cannot be
performed with the accuracy defined in the specifications section.
•Purging is allowed only if the system is in the wait state.

22 23

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P24 / P25）

Directions for use

Operation flowchart Suspending the infusion and changing the infusion rate / volume limit
■ To suspend infusion, press the “Stop / Silence Pi Pi Pi ……
key STOP ”. “Operation indicator (green)” will go
Power ON Press the “Power key ON
OFF ”.
off and the wait tone will sounds a short beep. VOL.
LIMIT BATTERY INDICATOR
TOTAL
VOL.

■ Pressing the “Up / Down key

mL
” in this SET UP

RATE ON
CHARGE
OFF
state can change the infusion rate. mL
／h

START

Attaching the IV set Attach an infusion bag or infusion ■ To set the volume limit, press the “Select key CLEAR STOP

bottle and IV set. SELECT ” once and display the “Volume limit display
SELECT SET
PURGE
SYSTEM ERROR

lamp”. The volume limit can be changed using

the “Up / Down key ” in this state.
Checking the IV set Use the “Up / Down keys ” ■ Pressing the “Start key START ” again to start the
to select the IV set to be used. infusion.

Setting the infusion rate Use the “Up / Down keys ”

to set the infusion rate.
Purging
■ While infusion is in progress, press the “Stop /
Setting the volume limit Use the “Up / Down keys ”
Silence key STOP ” to place the system in the
VOL.
LIMIT
TOTAL
VOL.
mL
BATTERY INDICATOR

to set the volume limit. SET UP

wait state. RATE

mL
／h
CHARGE
ON
OFF

■ Press the “Purge key ” once. will START

appear in the “Infusion rate display” for one CLEAR STOP

Eliminating air bubbles Press the “Purge key ”

second. SELECT SET
PURGE
SYSTEM ERROR

from IV set continuously while is on the

display to priming so that the ■ Release the “Purge key ”, then press the Press
twice
infusate reaches the tip of the needle. “Purge key ” while is displayed.
Purging will be performed as long as the “Purge key ” is held down.
Clearing the total volume Hold down the “Clear key CLEAR ” for
Caution
two seconds or more to clear the
priming volume. •The purging volume will be added to the total volume. (Volumes of
less than 1mL will not be added.)
•Purging cannot be performed during the infusion.
Introduce the IV set Introduce the needle of the IV set
into the patient. IV set used Purging infusion rate
TOP-H 999mL/h
15 drops/mL 400mL/h
Starting infusion Press the “Start key START ” to start 19 drops/mL 380mL/h
the infusion. 20 drops/mL 360mL/h
60 drops/mL 150mL/h

24 25

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P26 / P27）

Directions for use

Clearing the total volume Operation from the internal battery
■ Press the “Stop / Silence key STOP ” to suspend ■The system will operate from the internal battery if the AC or DC power supply is not
VOL.
BATTERY INDICATOR

connected.
LIMIT

system operation during infusion. TOTAL

VOL.
mL
SET UP

■ Hold down the “Clear key CLEAR ” for two

RATE
mL
／h
CHARGE
ON
OFF ■When power is shut off while the system is operating from the AC or DC power
supply, internal battery operation will be activated automatically. In this case the
seconds or more. START

CLEAR STOP
power supply switch alarm will be indicated.
SELECT SET
PURGE
SYSTEM ERROR ■The “Battery operation indicator” will illuminate while the system is
operating on battery power.
■The system can operate from the internal battery for approximately two hours＊1）.
■The residual internal battery power is displayed by three “Battery indicators” as a
conjecture. While the system is being recharged, the recharging progress will be
Terminating the infusion shown by an incrementing number of active indicators; during battery operation,
battery discharge is shown by a decreasing number of active indicators.
■ The empty container alarm is generated
when the infusion bag or infusion bottle “Battery indicator” state Guideline of residual battery power
becomes empty during normal infusion. One indicator ＊1）
illuminates Operation is possible for 15 minutes.
■ When the total volume has reached the Roller
clamp Two indicators Operation is possible for 30 minutes.
＊1）
pre-specified volume limit, the infusion illuminate
complete alarm is generated and will Three indicators Operation is possible for 60 minutes.
＊1）
illuminate
appear in the “Infusion rate display”. At this
Three indicators No battery power remaining.
time, the system will switch to the KVO are off
operation and infuse at approximately 1.0mL/h. Three indicators The battery or recharging circuit is faulty.
are flashing
■ To terminate the infusion at any point in time, press the “Stop / Silence
Key STOP ” to stop the infusion. ＊1）Operating conditions
   ・New battery (within one year from manufacture). ・After recharging for 24 hours.
■ To turn off power to the system, press the “Power key ON
OFF ” for two    ・Operating at 25mL/h using a TOP-H IV set.  ・Room temperature of 25℃.
seconds or more when the infusion is stopped. ■Recharging times required from fully discharged battery to following condition,
 in the state where system power is OFF.
Caution
 (1) Time required until one “Battery indicator” illuminates. ‥‥‥ Approx. 9 hours.
Close the roller clamp when the infusion is terminated or when the  (2) Time required until two “Battery indicators” illuminate. ‥‥‥ Approx. 13 hours.
power is turned off.  (3) Time required until three “Battery indicators” illuminate. ‥‥‥ Approx. 22 hours.
 (4) Time required until the system is fully recharged. ‥‥‥‥‥‥ Over 24 hours.

Replacing IV sets Caution

•If the internal battery is deteriorated, operation time shown by the “Battery
■ Repeat steps 7 through 15 under “Preparation before use • indicator” will decrease.
Commencement-of-work check”. •For the TOP-3300 model with the computer-integrated communication feature,
the operating time by internal battery will be shorter than that of the normal
specification model. The difference will be 20 minutes if the system had been
fully recharged.

26 27

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P28 / P29）

Directions for use

Adjusting the buzzer volume Using the equipotential terminal
■ Adjust the buzzer volume by turning the volume ■ For equipotentiality, connect the equipotential ground line to the
adjustment screw on the bottom of the system equipotential terminal on the back panel of the system.
using a screwdriver. Volume
adjustment
Using the pole clamp
Screwdriver
■ Use the optional pole clamp to secure the system to the infusion stand,
etc.
■ To secure the system to the pole clamp, turn the screw of the pole clamp
into the threaded hole on the bottom of the system.
Operation from DC power supply Caution
■ With the optional DC power cable, the system Secure the system to the pole clamp or infusion stand and check for
can operate from external DC power supply. stable system position.
Plug the DC power cable into the DC inlet on
the back of the system.
■ The DC power cable bears polarity marks
(＋,−). Avoid reversing the polarity when
Using the nurse call
connecting the power cable. ■ The alarm state of TOP-3300 can be
■ If the system is connected to the DC power transmitted via the Nurse call / Communication
supply, the “AC / DC power supply indicator”, connector.
“Battery charge indicator” and “DC power ■ Connect the nurse call cable to the Nurse call /
supply operation indicator” will illuminate to Communication connector on the back of the
indicate that the power supply is connected. system.
Caution Caution
•Reversing polarity when connecting the •Use the optional nurse call cable to make
power cable can damage the system or the connections to the nurse call interface.
external DC power supply. VOL. • Nurse call signal output is “Close” in alarm
LIMIT BATTERY INDICATOR
• To connect to an external DC power TOTAL
VOL.
state and “Open” in normal state. Use the
mL
supply, use a dedicated DC power cable. SET UP
internal system contact capacity of
• To fully recharge the internal battery, use RATE
mL
CHARGE
ON
OFF DC24V/1A with arbitrary connection
／h
15V DC from external DC power supply. polarity.
START

CLEAR STOP

PURGE

28 29

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P30 / P31）

Directions for use

Computer integrated communication (optional) Changing the IV set
■ For optional specification models, the Nurse call / communication ■ Once power is turned ON, the IV set type can VOL.
BATTERY INDICATOR
LIMIT

connector on the back panel of the system can be connected to the be selected. TOTAL
VOL.
mL
SET UP

medical monitoring system to monitor the status of the TOP-3300 pump. Each time the “Up / Down key ” is pressed, RATE
mL
／h
CHARGE
ON
OFF

the types of IV sets are displayed as shown

■ The system cannot be operated from the medical monitoring system. START

below. CLEAR STOP

■ The following table shows the communication specifications. All set values Press the “Set key SET ” to select the IV set to SELECT SET
PURGE
1
SYSTEM ERROR

are fixed. be used.

2
Communication system Conforms to RS-232C
Transmission rate 9600 bps VOL.
LIMIT BATTERY INDICATOR
TOTAL

Data bit 8 bits

VOL.
mL
SET UP

RATE ON

Parity check None ■ Press the “Set key ” to confirm current setting
CHARGE
mL OFF
SET ／h

Stop bit length 1 bit of IV set. START

CLEAR STOP

＊For details, of the computer integrated communication system, refer to the separate Available IV set SELECT SET
PURGE
SYSTEM ERROR

 document, “Operation Guide for Computer Integrated Communication System.” Display Available IV set Settings
TOP-H series dedicated IV set
Manufactured by TOP Corporation 20 drops/mL
General-purpose IV set 15 drops/mL
General-purpose IV set 19 drops/mL
General-purpose IV set 20 drops/mL
General-purpose IV set 60 drops/mL

Caution
•IV set setting can not be changed after IV set setting selected.
Turn pump off and on again after changing IV set type.
•Using TOP-H series dedicated IV set to perform infusion with 5% of
infusion accuracy.

30 31

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P32 / P33）

Troubleshooting
＊The buzzer sound can be silenced by pressing the “Stop / Silence key STOP ” The alarm buzzer is silenced by pushing the “Stop / Silence key STOP ”.
 except for faults in the system. The alarm is reset with a second push on the “Stop / Silence key STOP ”.
Alarm indication and buzzer sound Cause Action
The infusion bottle or infusion bag is empty. To continue the infusion after the infusion fluid has run out, replace the infusion bottle
or infusion bag with a spare.
Empty container If the infusion fluid has not run out, check if the drop sensor was attached in the normal
Long beep position or if it is tilted abnormally.

The infusion line is occluded. Clamp the infusion line and remove the cause of the occlusion.
To resume infusion, always perform priming.
Occlusion alarm Caution
Long beep Occlusions due to kinked tubes and clotted filters or cannulas in the infusion line
can result in internal high pressure in the infusion line.
Removing the cause of the occlusion in this state will cause excessive amounts
of infusion fluids to be injected temporarily.
Take appropriate action such as clamping the infusion line before removing the
cause of the occlusion.

The total drop count exceeds the specified value The following causes may be suspected : •Free-flow of Infusion fluid.
by ±5 drops. •Infusion fluid with larger specific gravity is used. •The tube of the IV set is distorted due to
•Infusion fluid contains a surface active agent. prolonged infusion.
Flow rate alarm (TOP-H series dedicated IV set is used.) •IV set used is other than the specified one.
•An IV set other than the TOP-H series dedicated
Long beep IV set is used. •The drip nozzle of the IV set is wet due to
•Drop sensor is not attached in the proper position. prolonged use, generating larger drops.
•Drip chamber is tilted.

The door is open or there is a possibility that the Check that the door is shut properly.
door is not surely closed. If this alarm is generated even if the door is shut properly, stop using the system and
Door open alarm contact the dealer you purchased the product from.
Long beep

The difference between the total drop count and Suspected causes are as follows : •Free-flow of Infusion fluid.
the specified value has exceeded ±10 drops. •Infusion fluid with larger specific gravity is used. •The tube of the IV set is distorted due to
•Infusion fluid contains a surface active agent. prolonged infusion.
Flow rate alarm (General-purpose IV set is used.) •IV set used is other than the specified one.
•Drop sensor is not attached in the proper position.
Long beep •Drip chamber is tilted. •The drip nozzle of the IV set is wet due to
prolonged use, generating larger drops.

Air bubbles are present in the tube of the Eliminate air bubbles from the tube of the IV set and insert the tube up to the innermost
IV set. area of the air-in-line sensor.
Air-in-line alarm
Long beep

32 33

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P34 / P35）

Troubleshooting
Alarm indication and buzzer sound Cause Action
Drop sensor is not connected or the sensor has Check for connection of the drop sensor. If these alarms recur even if the drop sensor
a wire break. is securely connected, a wire break in the drop sensor must be suspected.
Drop sensor connection In this case, immediately stop using the system and contact the dealer you purchased
alarm the product from.
Long beep

Door is opened during infusion or door is not Check that the door is closed or open and close the door once. If this alarms recurs
closed properly. Door has not been opened / even if the door is closed properly, a malfunction in the door sensor must be
Door operation closed after power ON. suspected. In this case, immediately stop using the system and contact the dealer you
Long beep purchased the product from.

Infusion is complete (when volume limit is set). To continue infusion, replace the infusion bottle or infusion bag with a spare.

“Flashing”
Infusion complete
Long beep

The internal battery has no power left to drive Connect to AC power supply or external DC power supply immediately.
the system. Turn power OFF to reset the alarm, then turn power ON the power again.
Auto power off Caution
Long beep It will take some minutes until the alarm is reset, if battery power is significantly
low, even if the power cable is connected. If the alarm indicator is still ON after
five minutes have elapsed after power on, it must be suspected that the internal
battery is faulty. Call for repairs in this case.

Equipment fault If this alarm persists, it must be suspected that there is a fault in the system.
Contact the dealer you purchased the product from.
： ∼ 、 、 、 、 、 、 、 、
Caution
Malfunction The alarm sound cannot be silenced by pressing the “Stop/Silence key STOP ”.
Long beep To silence the alarm, turn power OFF by pressing the “Power key OFF
ON
”.

Flashing “infusion rate The system was suspended for over three Instead of leaving the system suspended for a substantial period during internal battery
display” minutes during operation from internal battery. operation, turn power OFF in order to prevent unnecessary loss of internal battery power.
Caution
Reminder alarm If the system is left in the alarm state for another three minutes, power will be
Long beep shut off automatically.

34 35

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P36 / P37）

Troubleshooting
Alarm indication and buzzer sound Cause Action
Voltage of internal battery is low. Connect to AC power supply or connect to external DC power supply immediately.

“Flashing”
Low battery alarm
Short beep

Internal battery is not connected to the system Stop using the system immediately and contact the dealer you purchased the product
or wiring of the internal battery may be broken from.
(This error occurs during the system is operated
“Flashing”
from AC / DC power supply).
Battery malfunction
alarm
Short beep

Internal battery is not connected to the system Stop using the system immediately and contact the dealer you purchased the product
or wiring of the internal battery may be broken from.
Battery connection (This error occurs during power ON self-diagnosis).
alarm
Long beep

“Alarm sound” Power is no longer supplied from AC or DC AC power cable is disconnected, or a wire is broken.
Power supply switch power supply ; system is operating from internal Check the power supply used and properly connect the power supply to the system.
alarm battery.
Short beep

TOP-3300 cannot be A fuse may have blown. Check the fuses (total 2) and if any fuse is blown, contact the dealer you purchased
operated from an AC the product from.
power supply after
“Power key OFF
ON
”
was pressed.

36 37

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P38 / P39）

Selection of settings
How to select set values List of settings
1. Turn ON the power while pressing the “Set key VOL.
LIMIT
TOTAL
VOL.
mL
BATTERY INDICATOR
TOP-H series dedicated IV set setting
SET ” and “Stop / Silence key STOP ” SET UP

RATE
mL
／h
CHARGE
ON
OFF
Setting TOP-H series dedicated IV set used
simultaneously. ＊
20 drops/mL
START
2
2. The system will display up to on CLEAR STOP

“Volume limit / Total volume display” and will PURGE Occlusion detection pressure setting (for TOP-H series dedicated IV set )
SELECT SET SYSTEM ERROR

then enter the setting selection mode. Release Setting Occlusion detection pressure
the “Set key SET ” and “Stop / Silence key STOP ”. High (160kPa or below)
1 ＊
3. Modes will be switched each time the “Select Medium (120kPa or below)
key SELECT ” is pressed. VOL.
LIMIT BATTERY INDICATOR
Low (80kPa or below)
TOTAL
VOL.

4. To change set values, use the “Up / Down key

mL
SET UP Minimum (40kPa or below)
RATE ON
CHARGE
mL OFF
／h
”. Occlusion detection pressure setting (for general-purpose IV set)
START

5. Turn OFF the power to exit the setting selection CLEAR STOP Setting Occlusion detection pressure
mode. PURGE Changing ＊
SELECT SET
set values
SYSTEM ERROR
High (160kPa or below)
Low (80kPa or below)
Selecting mode
Infusion data storage setting Buzzer setting
Selecting mode Changing set values Infusion Volume Total Wait Operation Alarm
Setting rate limit volume Setting tone tone sound
Use the “Select key SELECT ” Use the “Up / Down keys ” ＊ ＊
to select modes to change set values

Data storage setting

：Stored ：Not stored ：Enabled ：Disabled
Buzzer setting Power supply warning setting
Setting Power supply switch warning Low battery warning
Power supply warning setting ＊
Continuous sound Continuous sound
5 seconds Intermittent 3 seconds
Occlusion detection pressure setting
(for TOP-H series dedicated IV set)
Air-in-line detection level setting
Occlusion detection pressure setting Setting Air-in-line detection level Frequency
(for general-purpose IV set) High 50μL
＊
Medium 0.1mL/15minutes
TOP-H series dedicated
IV set setting Low 1mL /15minutes
＊：Default settings at shipment
Air-in-line detection
level setting

38 39

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P40 / P41）

Maintenance
Cleaning, Sterilization Periodic maintenance
■ Always keep the system clean. Use a soft cloth dampened with warm Safe use of this system requires periodic manitenance. Perform the following
water to wipe off infusion fluid drops on exterior surface. maintenance once every six months.
■ If disinfection is necessary, use the following disinfecting agent. After using 1. Checking the appearance
the agent, wipe off it with a soft cloth dampened with water or warm water.
■ Check the system housing for cracks and flaws.
Disinfection Dilution ■ Check operation panel for breaks and flaws.
Chlorhexidine gluconate Solution 2.5mL + purified water 97.5mL
2. Checking the infusion rate
Glutaral Solution 10mL + purified water 90mL + buffer agent 0.57g
■ Use a measuring cylinder and stop watch to approx.
Benzalkonium chloride Solution 0.5mL + purified water 100mL
perform infusion rate check. Test condition is as 50cm
When using the disinfecting agent, follow the caution of each agent. specified in table below :
IV set used Infusion rate Time Volume
■ Sterilize the system using EOG (Ethylene Oxide Gas) at a temperature of more
58℃ or less and relative humidity of 60% or less. TOP-H 600mL/h 5 minutes 47.5∼52.5mL Measuring
than
50cm
After sterilization, ventilate the room for over 24 hours or place system in General purpose 150mL/h 6 minutes 13.5∼16.5mL
cylinder
aerator for over 8 hours.
The above is only a guideline. Use adequate method to check 3. Checking the alarm function
sterilization results. ■ Door open alarm
Check the display and alarm sound by
Caution opening the door during infusion.
•Avoid wiping the system with solvents like alcohol and thinner. ■ Occlusion alarm
•Turn off power and disconnect AC and DC power cables before Start infusion using the parameters below and
cleaning the system. close roller clamp. Measure the times from start close
of infusion to occurrence of occlusion alarm and roller clamp
check the time is in the specified range. Check
Environment-friendly disposal, recycling display and alarm sound at that point, too.
■ Remove the internal Ni-Cd batteries before disposing of the TOP-3300. The internal
Ni-Cd batteries contains an environmentally hazardous material (cadmium). Occlusion detection
IV set used IV set setting Infusion rate Time
pressure setting
■ Return used the internal Ni-Cd batteries to the dealer you purchased the product
from or dispose of them in accordance with the applicable laws and regulations. TOP-H TOP-H 100mL/h Under 1 minute

■ The dealer you purchased the product from will accept TOP-3300 which are no General purpose Individual setting 100mL/h Under 1 minute
longer used for proper recycling.
■ Air-in-line alarm
Start infusion after adding air bubbles of over 10mm in the tube of the IV set.
Check if is displayed and an alarm sounds at that point, too.
(When the air-in-line detection level setting is )

40 41

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P42 / P43）

Maintenance
Maintaining battery performance Removing / installing the internal battery
■ The internal battery is a consumable. If it is depleted, it must be replaced. 1. How to remove the internal battery Ni-Cd battery
If you want to replace batteries, contact the dealer you purchased the (1) Use a screwdriver to loosen the battery
product from. cover fixing screws on the bottom of the
system.
Model : BP-53 (12V, 700mAh) (2) Remove the battery cover.
(3) Remove the internal battery.
■ To ensure proper performance of the internal battery, perform the internal (4) Disconnect the battery cable connector.
battery operation to depletion once every month until infusion is
automatically stopped (OFF will appear on the display) and refresh the 2. How to install the internal battery
internal battery. After the refresh operation is complete, recharge the (1) Insert the connector of the battery cable into
internal battery for over 24 hours for next use. the battery.
(2) Insert the internal battery into the battery box.
■ Perform the following inspections on the battery every 6 months : (3) Attach the battery cover.
(1) Connect to the AC or DC power supply to recharge the battery for over (4) Use a screwdriver to tighten the screw fixing the battery cover.
24 hours.
(2) Turn ON the power and attach the IV set. Caution
(3) Set the infusion rate to 25mL/h and start infusion. The battery indicator is reset to 0 after the internal battery has been
(4) Operate the system until it stops infusing due to low battery alarm. replaced with a new one. Recharge the internal battery for over 24
•If the time from the start of the infusion to end of operation is 90 hours before use.
minutes or more, the internal battery condition is good.
•If the time from the start of the infusion to end of operation is 60 to 90
minutes, the internal battery condition is reaching its service life.
•If the time from the start of the infusion to end of operation is less than
60 minutes, the internal battery has reached its service life. Replace
the internal battery with spare.
(5) When the internal battery level check is complete, recharge the battery
for next use.

42 43

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P44 / P45）

Specifications
Description TOP infusion pump Special features KVO (Keep Vein Open) : After programmed infusion volume has been
Model TOP-3300 delivered, infusion is continued at a minimal rate
to prevent clot formation.
Power supply AC power supply (commercially available) : AC100-240V±10% 50/60Hz
Auto power OFF : If the system is left in the suspend state or alarm
External DC power supply : DC12.7-15V
state for approximately three minutes while it is
Internal battery : Rechargeable, DC12V 700mAh Ni-Cd powered by an internal battery, a buzzer will
Model : BP-53 sound; if left in this state for another three minutes
Continuous operation : Approx. two hours (when a power to the system will be automatically shut off.
new battery is fully recharged with 25mL/h set) Repeat alarm : If two minutes elapsed without resetting the alarm
after it was silenced, the alarm will sound again.
Input current AC power supply : 0.3A   External DC power supply : 0.7A
Data storage : Infusion rate set, volume limit and total volume
Applicable IV sets TOP-H series dedicated IV set can be stored.
General-purpose 15drops/mL, 19drops/mL, 20drops/mL, or 60drops/mL IV set
Buzzer setting : Presence/Absence of wait tone and operation
Flow rate range 1.0 - 999mL/h (TOP-H series dedicated IV set ) tone can be specified.
1.0 - 400mL/h (General-purpose 15drops/mL IV set) Power supply : The system has entered the internal battery
1.0 - 380mL/h (General-purpose 19drops/mL IV set) switch operation mode when power is no longer
1.0 - 360mL/h (General-purpose 20drops/mL IV set) supplied from the AC/DC power supply.
1.0 - 150mL/h (General-purpose 60drops/mL IV set) Operating Ambient temperature : 5 - 40℃
conditions Relative humidity : 20 - 90% (noncondensing)
Increments
Atmospheric pressure : 70 - 106kPa
1.0 - 99.9mL/h in 0.1mL/h increments
100mL/h - maximum infusion rate in 1mL/h increments Transport and Ambient temperature : -10 - 45℃
storage Relative humidity : 10 - 90% (noncondensing)
Total volume display 1 - 9999 mL in 1mL increments conditions
Atmospheric pressure : 50 - 106kPa
Infusion ・Using TOP-H series dedicated IV set : ±5%
accuracy＊ ・Using general-purpose IV set : ±10% Classification ClassⅠ, Type CF, IPX1 (Drip proof)
Fuse T 1A
Air-in-line 3-step selection
detection＊ External dimensions 90（W）× 216（H）× 209（D）mm
50µL 0.1mL/15 minutes 1mL/15 minutes
Weight Approx. 2.6kg
Occlusion 4-step selection (using TOP-H series dedicated IV set)
detection Accessories Drop sensor × 1     AC power cable × 1
P1-3 : Under 160.0kPa / Under 1200mmHg / Under 1.63kgf/cm2
pressure＊ Operation Guide × 1
P1-2 : Under 120.0kPa / Under 900mmHg / Under 1.22kgf/cm2
P1-1 : Under 80.0kPa / Under 600mmHg / Under 0.82kgf/cm2 Materials used Case ：ABS (Acrylonitrile Butadiene Styrene)
2 Door/Front frame ：Aluminum Die Casting
P1-0 : Under 40.0kPa / Under 300mmHg / Under 0.41kgf/cm
Occlusion sensor ：Reinforced PBT with Glass Fiber
2-step selection (using general-purpose IV set)
Air-in-Line sensor ：Polycarbonate
P2-1 : Under 160.0kPa / Under 1200mmHg / Under 1.63kgf/cm2
Door handle ：Reinforced Nylon with Glass Fiber
P2-0 : Under 80.0kPa / Under 600mmHg / Under 0.82kgf/cm2
Tube clamp ：Reinforced PBT/PC with Glass Fiber
Alarm Empty container, Occlusion＊, Flow rate, Door open, Air-in-line, Operation panel ：Polyester Film
Drop sensor connection＊, Infusion complete, Battery malfunction, Indicator cover ：Polycarbonate
Battery connection, Low battery, Malfunction＊, Reminder, Repeat,
＊; Essential performance : critically affects the safety of patients if it is not operated
Power supply switch according to specifications. (IEC/EN 60601-1-2)

44 45

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P46 / P47）

Specifications
Options Technical Data
The technical data indicates the essential performances are suited to the
Name following environments.
TOP infusion stand Guidance and manufacturer’s declaration – electromagnetic emissions
Multiple pump stand TOP-3300 is intended for use in the electromagnetic environment specified below.
Multiple connection cable The customer or the user of TOP-3300 should assure that it is used in such an
environment.
Pole clamp (can be attached to φ19-φ30mm poles)
Emissions test Compliance Electromagnetic environment - guidance
External DC power cable
RF emissions TOP-3300 uses RF energy only for its internal
Nurse call cable function. Therefore, its RF emissions are very
Group 1 low and are not likely to cause any interference
3m CISPR 11 in nearby electronic equipment.
D-SUB 9-pin Male - D-SUB 25-pin Male 5m RF emissions TOP-3300 is suitable for use in all
10m establishments, including domestic
Class B establishments and those directly connected
Communication cable
3m CISPR 11 to the public low-voltage power supply
network that supplies buildings used for
D-SUB 9-pin Male - D-SUB 9-pin Female 5m Harmonic domestic purposes.
emissions
10m Class A
IEC61000-3-2
Voltage fluctuations /
flicker emissions
Complies
IEC61000-3-3

46 47

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P48 / P49）

Specifications
Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity
TOP-3300 is intended for use in the electromagnetic environment specified below. TOP-3300 is intended for use in the electromagnetic environment specified below.
The customer or the user of TOP-3300 should assure that it is used in such an environment. The customer or the user of TOP-3300 should assure that it is used in such an environment.
IEC60601 Electromagnetic IEC60601 Compliance Electromagnetic
Immunity test test level Compliance level environment - guidance Immunity test test level level environment - guidance
Electrostatic ± 6kV contact ± 8kV contact Floors should be wood, concrete or Portable and mobile RF communications
discharge (ESD) ceramic tile. If floors are covered equipment should be used no closer to
± 8kV air ± 15kV air with synthetic material, the relative any part of TOP-3300, including cables,
IEC61000-4-2 humidity should be at least 30%. than the recommended separation
distance calculated from the equation
IEC60601-2-24 applicable to the frequency of the
transmitter.
Electrical fast ± 2kV ± 2kV Mains power quality should be that Recommended separation
transient / burst for power supply for power supply of a typical commercial or hospital distance
lines lines environment. Conducted RF 3Vrms 10Vrms d = 0.35√P
IEC61000-4-4 150kHz to 80MHz
± 1kV ± 1kV IEC61000-4-6
for input / output for input / output
lines lines
Radiated RF 3V/m 10V/m d = 0.35√P 80MHz to 800MHz
Surge ± 1kV ± 1kV Mains power quality should be that 80MHz to 2.5GHz d = 0.70√P 800MHz to 2.5GHz
Lines to lines Lines to lines of a typical commercial or hospital IEC61000-4-3
IEC61000-4-5 environment. where P is the maximum output power
± 2kV ± 2kV
Lines to earth Lines to earth rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
Voltage dips, < 5% UT < 5% UT Mains power quality should be that separation distance in metres (m).
short (> 95% dip in UT) (> 95% dip in UT) of a typical commercial or hospital
interruptions for 0.5 cycle for 0.5 cycle environment. If the user of
and voltage TOP-3300 requires continued Field strengths from fixed RF
variations on 40% UT 40% UT operation during power mains transmitters, as determined by an
power supply (60% dip in UT) (60% dip in UT) interruptions, it is recommended electromagnetic site survey,a should be
input lines for 5 cycles for 5 cycles that TOP-3300 is powered from less than the compliance level in each
an uninterruptible power supply or frequency range. b
IEC61000-4-11 70% UT 70% UT a battery.
(30% dip in UT) (30% dip in UT) Interference may occur in the vicinity of
for 25 cycles for 25 cycles equipment marked with the following
symbol :
< 5% UT < 5% UT
(> 95% dip in UT) (> 95% dip in UT)
for 5s for 5s
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
Power frequency 3A/m 400A/m The power frequency magnetic field NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
magnetic field should be in the level at location of affected by absorption and reflection from structures, objects and people.
(50 / 60Hz) a typical commercial or hospital a
environment. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
IEC61000-4-8 telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
IEC60601-2-24 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 TOP-3300 is used
exceeds the applicable RF compliance level above, TOP-3300 should be observed to
verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating TOP-3300.

NOTE UT is the a.c. mains voltage prior to application of the test level. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 10V/m.

48 49

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P50 / P51）

Specifications
Recommended separation distances between
portable and mobile RF communications equipment and TOP-3300 Infusion Accuracy Information
TOP-3300 is intended for use in an electromagnetic environment in which radiated RF ■ The following infusion accuracy graphs show the performance after the
disturbances are controlled. The customer or the user of TOP-3300 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and start of infusion and the maximum expected variation in infusion rate over
mobile RF communications equipment (transmitters) and TOP-3300 as recommended defined periods (2, 5, 11, 19, and 31minutes) after the normal infusion rate
below, according to the maximum output power of the communications equipment.
is reached, in accordance with IEC60601-2-24:1998.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter ■ This information is intended for the user to determine the suitability of this
W 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz infusion pump to provide the appropriate therapy. In particular when used
d = 0.35√P d = 0.35√P d = 0.7√P
with critical drugs, the user should consider the drug characteristics (such
0.01 0.035 0.035 0.070
as half life, minimum effective concentration, minimal toxic concentration)
0.1 0.11 0.11 0.22
and the selected infusion rate.
1 0.35 0.35 0.70
10 1.1 1.1 2.2
■ As is typical for infusion pumps, a slow start and substantial short term
100 3.5 3.5 7.0
variations are possible at low infusion rates such as 1mL/h.
For transmitters rated at a maximum output power 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 80MHz and 800MHz, the separation distance for the higher frequency range Caution
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is •Particular attention should be paid to :
affected by absorption and reflection from structures, objects and people. ・Neonatal and infant patients, where lower flow rates and smaller
volumes may be expected.
・Use with critical drugs with a short half-life such as catecholamine.
Maximum delay for activation of occlusion alarm and
bolus volume In such cases, it is necessary to dilute the drug and increase infusion
rate or consider use of the infusion pump allowing stable infusion at low
Occlusion detection Infusion rate rate or small precise volumes.
pressure set value Maximum delay Bolus volume

1mL/h 1 hour 25 min 20 sec 1.256mL •The graphs below are based on tests with normal water and the 18G
P1-3：160kPa needle, under the expected range of back pressure and container head
25mL/h 2 min 59 sec 1.208mL height.
1mL/h 1 hour 2 min 34 sec 0.928mL Infusion with fluids of high viscosity, narrow gauge needles and high
P1-2：120kPa positive / negative pressure may result in additional variations.
25mL/h 2 min 12 sec 0.892mL
1mL/h 40 min 20 sec 0.607mL
P1-1：80kPa
25mL/h 1 min 26 sec 0.584mL
1mL/h 17 min 34 sec 0.278mL
P1-0：40kPa
25mL/h 39 sec 0.268mL

＊TOP-H series dedicated IV set from TOP is used.

 The Maximum delay and bolus volume are influenced by the test conditions.

50 51

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P52 / P53）

Specifications
Start-up curves : Data collected during two hours of measurement period is plotted Trumpet Curves : Flow error during infusion for a short duration (PΔt)
Sample intervals : Δt=0.5min Sample intervals Δt=0.5min
Infusion rate Q(mL/h) Observation window duration PΔt=2, 5, 11, 19, 31min
Test period T=120min Maximum measured error in observation window of specified duration Epmax (%)
Minimum measured error in observation window of specified duration Epmin (%)
Overall mean percentage of flow error measured A (%)
Infusion rate = 1mL/h Infusion rate = 25mL/h Infusion rate = 1mL/h Infusion rate = 25mL/h
2.0 50 15 15
1.8 45 Epmax
1.6 40 10 10
Epmax

Deviation (%)

Deviation (%)
1.4 35 5 5
Q (mL/h)

Q (mL/h)
1.2 30 A
1.0 25 0 0 Epmin
0.8 20 Epmin
-5 -5
0.6 15
0.4 10 -10 -10
0.2 5
0.0 0 -15 -15
0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 2 5 11 19 31 2 5 11 19 31
T (min) T (min) PΔt (min) PΔt (min)

Infusion rate = 1mL/h (After 24 hours) Infusion rate = 25mL/h (After 24 hours) Infusion rate = 1mL/h (After 24 hours) Infusion rate = 25mL/h (After 24 hours)
2.0 50 15 15
1.8 45
1.6 40 10 10
Epmax

Deviation (%)

Deviation (%)
1.4 35 5 5
Epmax
Q (mL/h)

Q (mL/h)

1.2 30
A A
1.0 25 0 0
Epmin
0.8 20
-5 -5
0.6 15
0.4 Epmin
10 -10 -10
0.2 5
0.0 0 -15 -15
0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 2 5 11 19 31 2 5 11 19 31
T (min) T (min) PΔt (min) PΔt (min)

Applicable standard : IEC60601-2-24

52 53

トップ 輸液ポンプ TOP-3300 (英文)

印刷使用色：２色 作成倍率：100％ 寸法（W×H）
：297×210mm
PANTONE 2736 C (ブルー) スミ 取扱説明書（P54 / P55）

Recommended Administration IV sets Glossary

■ Use a TOP-H series dedicated IV set manufactured by TOP Corporation.
Otherwise use a tube equipped with a lure lock type connector bearing the
Symbols
CE marking which can assure connection of other medical equipment.
Symbols printed on TOP-3300 main body
Caution
Symbols Description
•If a tube equipped with a slip tip connector is used, a loose
connection will result. Type CF equipment : Degree of protection against electrical
•If an IV set other than the TOP-H dedicated IV set is used, infusion shock ; equipment intended for DIRECT CARDIAC APPLICATION.
may not be performed with the accuracy given in the specifications,
due to influence of the viscosity and specific gravity of the infusion Alternating current
fluid used.

Direct current.

IPX1 Protection against vertical drops of water.

Equipotential connector : Terminal for connection of device

to equipotential base of the electric facility.

Year of manufacture.

Continuous adjustment : Rotate knob to adjust volume of

alarm sound.

Caution, Refer to accompanying documents.

Dispose of using an environmental-friendly method (battery).

Cd

Recycling mark (Battery).

Device complies with the requirements of EC Medical

Device Directive 93/42/EEC 1993/6/14
0123 : Notified Body : TÜV SÜD Product Service GmbH

54 55

トップ 輸液ポンプ TOP-3300 (英文)