Revision History

Ver. Section Description Revised by Date

C0 Document creation X．Jiang 2015-3-3

INfusia VP7
Volumetric Infusion Pump

INSTRUCTIONS FOR USE

FOR VETERINARY USE ONLY
Description of the symbols used on the device and its packaging

Device identification label symbols

Symbol Description

Product serial number

Name of manufacturer

Date of manufacture

Part included in a recycling process

Index of protection against splashing liquids

Protection against leakage current; type CF applied part

Protective earth (ground)

Refer to the Instructions For Use

NRTL mark

Packaging symbols

Symbol Description

Fragile, handle with care

This way up

Keep away from rain

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

For more information on temperature, pressure and humidity limitations, please refer to Section 1.5
Use environment in Chapter 1 Introduction.

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Release Notes

Date Software Revision Description

Version
October 1.0 01 The 01 version of the instructions for use
2016

Local contacts for servicing and use issues

Fill this box with your distributor seal:

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Table of Contents

Description of the symbols used on the device and its packaging ......................................................................... 1
Device identification label symbols .................................................................................................................. 1
Packaging symbols ............................................................................................................................................. 1
Release Notes .............................................................................................................................................................. 2
Table of Contents ....................................................................................................................................................... 3
1 Introduction ............................................................................................................................................................ 6
1.1 Explanation of symbols ............................................................................................................................... 6
1.2 Scope ............................................................................................................................................................. 6
1.3 Intended use ................................................................................................................................................. 6
1.3.1 Intended user population ..................................................................................................................... 6
1.3.2 Intended patient population ................................................................................................................ 7
1.4 Contraindications ........................................................................................................................................ 7
1.5 Use environment .......................................................................................................................................... 7
1.6 Infusion modes ............................................................................................................................................. 7
1.7 Precautions to be taken ............................................................................................................................... 8
2 Description .............................................................................................................................................................. 9
2.1 System definition.......................................................................................................................................... 9
2.2 Packaging contents ...................................................................................................................................... 9
2.3 Pump ............................................................................................................................................................. 9
2.3.1 Front view ........................................................................................................................................... 9
2.3.2 Back view ......................................................................................................................................... 10
2.4 User interface ..............................................................................................................................................11
2.4.1 Front panel .........................................................................................................................................11
2.4.2 Display .............................................................................................................................................. 12
2.4.3 The drip chamber symbol ................................................................................................................. 12
2.5 Drop sensor ................................................................................................................................................ 13
3 Installation............................................................................................................................................................. 14
3.1 Global installation...................................................................................................................................... 14
3.2 Installing the pump .................................................................................................................................... 15
3.3 Loading the administration set ................................................................................................................. 15
3.3.1 Administration set recommendations ............................................................................................... 15
3.3.2 Loading procedure ............................................................................................................................ 16
3.4 Connecting the drop sensor ...................................................................................................................... 17
4 Operations ............................................................................................................................................................. 19
4.1 Electrical connection / disconnection ....................................................................................................... 19
4.1.1 Electrical connection......................................................................................................................... 19
4.1.2 Electrical disconnection .................................................................................................................... 19
4.2 Operating on battery ................................................................................................................................. 19
4.2.1 Battery precautions ........................................................................................................................... 20
4.2.2 Battery operating mode ..................................................................................................................... 21
4.2.3 Battery charging system.................................................................................................................... 21
4.3 Administration set calibration .................................................................................................................. 21

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 4.4 Basic operations ......................................................................................................................................... 22
4.4.1 Switch on and off .............................................................................................................................. 22
4.4.2 Start or stop infusion ......................................................................................................................... 23
4.4.3 Rate mode ......................................................................................................................................... 24
4.4.4 Time mode ........................................................................................................................................ 25
4.4.5 Volume mode.................................................................................................................................... 26
4.4.6 Bolus setup and function................................................................................................................... 27
4.4.7 Purge ................................................................................................................................................. 28
4.4.8 KVO (Keep Vein Open) ................................................................................................................... 29
4.4.9 Change flow rate setting during infusion .......................................................................................... 29
4.5 History records........................................................................................................................................... 30
4.5.1 Export history logs ............................................................................................................................ 30
4.5.2 Set date and time ............................................................................................................................... 30
4.6 Software version check .............................................................................................................................. 31
4.7 Device reset ................................................................................................................................................. 31
5 Cleaning and disinfecting ..................................................................................................................................... 32
5.1 Prohibited cleaning and disinfecting agents ............................................................................................ 32
5.2 Precautions for cleaning ............................................................................................................................ 32
5.3 Cleaning and disinfecting guidelines ........................................................................................................ 32
6 Alarms .................................................................................................................................................................... 33
6.1 Alarm information ..................................................................................................................................... 33
6.2 Alarm conditions and corrective actions.................................................................................................. 34
6.3 Intelligent alarm system ............................................................................................................................ 35
6.4 Features of alarm signals .......................................................................................................................... 35
6.5 Alarm silence .............................................................................................................................................. 35
6.6 Alarm dismissal.......................................................................................................................................... 36
6.7 Volume of audible alarm signals .............................................................................................................. 36
6.8 Maximum alarm delay .............................................................................................................................. 36
7 Troubleshooting .................................................................................................................................................... 37
7.1 Troubleshooting guide ............................................................................................................................... 37
7.2 Error messages ........................................................................................................................................... 40
8 Technical Information .......................................................................................................................................... 43
8.1 Performance ............................................................................................................................................... 43
8.1.1 Infusion flow rate .............................................................................................................................. 43
8.1.2 Volume to be infused ........................................................................................................................ 43
8.1.3 Infusion time ..................................................................................................................................... 43
8.1.4 Purge rate .......................................................................................................................................... 43
8.1.5 Bolus rate .......................................................................................................................................... 43
8.1.6 Bolus volume to be infused .............................................................................................................. 43
8.1.7 KVO rate........................................................................................................................................... 43
8.1.8 Occlusion alarm pressure level ......................................................................................................... 43
8.1.9 Occlusion alarm response time ......................................................................................................... 44
8.1.10 Bolus volume at occlusion release .................................................................................................. 44
8.2 Technical characteristics ........................................................................................................................... 44

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 8.2.1 Operation mode ................................................................................................................................ 44
8.2.2 Power supply specifications.............................................................................................................. 44
8.2.3 Battery specifications ........................................................................................................................ 45
8.2.4 Power consumption........................................................................................................................... 45
8.2.5 Sensitivity of Air Sensor ................................................................................................................... 45
8.2.6 Dimensions – Weight........................................................................................................................ 45
8.2.7 Compliance with standards ............................................................................................................... 45
8.3 Start-up and Trumpet Curves .................................................................................................................. 45
8.3.1 Start-up curves .................................................................................................................................. 46
8.3.2 Trumpet curves ................................................................................................................................. 46
9 EMC Declaration .................................................................................................................................................. 48
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND
SYSTEMS......................................................................................................................................................... 48
Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and
SYSTEMS......................................................................................................................................................... 48
Guidance and manufacturer´s declaration – electromagnetic immunity – for LIFE-SUPPORTING ME
EQUIPMENT and ME SYSTEMS ................................................................................................................ 49
Recommended separation distances between portable and mobile RF communications equipment and
the EQUIPMENT or SYSTEM -for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS ...... 51
10 Device Storage and Transport ........................................................................................................................... 52
10.1 Storage and transport conditions ........................................................................................................... 52
10.2 Preparing for storage............................................................................................................................... 52
10.3 Using after storage ................................................................................................................................... 52
11 Services ................................................................................................................................................................ 53
11.1 Maintenance ............................................................................................................................................. 53
11.1.1 Regular inspections ......................................................................................................................... 53
11.1.2 Battery............................................................................................................................................. 54
11.1.3 Fuses ............................................................................................................................................... 54
11.1.4 Drop sensor ..................................................................................................................................... 54
11.1.5 Device service life........................................................................................................................... 55
11.1.6 Disposal .......................................................................................................................................... 55
11.2 Warranty................................................................................................................................................... 55
11.2.1 General warranty conditions ........................................................................................................... 55
11.2.2 Limited warranty ............................................................................................................................ 55
11.2.3 Warranty conditions for battery and accessories ............................................................................ 55
12 Glossary of terms ................................................................................................................................................ 56

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1 Introduction

INfusia VP7 is a compact and comprehensive volumetric pump.

1.1 Explanation of symbols

Danger symbol:
Warning of an imminent hazard that could result in serious personal
injury and/or product damage if the written instructions are not
followed.

Warning symbol:
Warning of a potential hazard that could result in serious personal
injury and/or product damage if the written instructions are not
followed.

Information symbol:
Important information or recommendations to be followed.

1.2 Scope
These Instructions for Use (IFU) are applicable to the INfusia VP7 pump (hereafter referred to as
“pump” or “device”) with embedded software version 1.0.

Warning:
 Check that this IFU is applicable to the current pump software version. To find
the software version, see the “Software version check” section in Chapter 4
“Operations”.
 The user must adhere to the instructions specified in this IFU. Failure to adhere
to these instructions may result in damage to the equipment, injury to patients or
injury to users.

1.3 Intended use

INfusia VP7 is intended for use in clinical settings by trained veterinary professionals on animals
for continuous delivery of medications, nutrients, or other parenteral fluids through clinically
accepted IV routes of administration.
1.3.1 Intended user population

Warning:
 The pump must only be used and cleaned by trained veterinary healthcare
professionals.
 Keep the pump, administration sets and power cord away from unsupervised

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 children (and animals).

1.3.2 Intended patient population

The pump can be used on patients that require an accurately controlled infusion flow rate.
Danger:
The pump can be used on one patient at a time, and on multiple patients throughout
its lifetime.

1.4 Contraindications

 Do not use the pump in the following situations:

- Transfusion of blood and blood derivatives
- Explosive or flammable environment, due to risk of ignition
- Environments in which the pump is difficult to position securely
- Environments with strong electromagnetic radiation
 The pump is not designed for the following:
- Use in homecare
- Enteral nutrition

1.5 Use environment

The pump is intended for use in clinical settings.
Warning:
The pump should be used in the following operational conditions to ensure proper
performance:
 Operating temperature range:
- 41℉ to 104℉ (5°C to 40°C)
 Operating pressure range:
- 645 mmHg to 795 mmHg (860 hPa to 1060 hPa)
 Operating humidity range:
- 20% to 90% with no condensation

1.6 Infusion modes

The following infusion modes are available.

Mode Description
The infusion delivers a specified volume with a specified flow rate, and the flow
Rate mode
rate is monitored by the drop sensor.
The infusion delivers a specified volume within a specified time, and the flow
Time mode rate is determined by the infusion time and volume, and monitored by the drop
sensor.
Volume The infusion delivers a specified volume with a specified flow rate, and the flow

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 mode rate is controlled by adjusting the flow accuracy.

1.7 Precautions to be taken

 Take the time to read and understand this “Instructions for Use” manual before operating the
device.
 Do not service or modify the device without authorisation from the manufacturer.
 Do not use the device in conjunction with other flow control devices.
 Device performance is independent of gravity in the specified operating conditions.
 This device is Class I equipment. To avoid the risk of electric shock, the equipment must only
be connected to the mains supply with a protective ground connection.
 Connecting additional devices to the pump may increase leakage current. To ensure user and
patient safety, responsible organisations must consider the requirements of IEC 60601-1-1 and
other related standards listed in the table in Section 8.2.7.
 The device is designed for installation on a pole or securely attached to a cage or stall.
 Administration sets used with the device should comply with the ISO standard 8536.
 Clearly identify the type of administration set to be used is for adults (1mL = 20 drops) or for
children (1mL = 60 drops).
 Do not connect the administration set to the patient when purging.
 If any ingress of fluids is suspected, switch off and unplug the device immediately. Contact the
authorised distributor before cleaning and using the device again.
 If any malfunctions occur and the device must be repaired, or for product descriptions, circuit
diagrams, parts or any other information, please contact Fresenius Kabi US LLC.

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2 Description

2.1 System definition

The INfusia VP7 infusion system comprises the pump, power cord, drop sensor and connection
cable.

2.2 Packaging contents

The INfusia VP7 packaging contains the following:
 1 INfusia VP7 pump
 1 Drop sensor and the connection cable
 1 “Instructions for use” manual
 1 Power cord
 1 Quality Control certificate
 1 Packing list

Information:
If packaging contents are incomplete or show sign of damage, please contact
Fresenius Kabi US LLC.

2.3 Pump

2.3.1 Front view

Legend:
1 Handle
2 Front Panel
3 Pump Door
4 Door Lever

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2.3.2 Back view

Legend:
1 Label
2 12 VDC Socket (optional）
3 RS232 Port
4 Reset Hole
5 Pole Clamp
6 Speaker Holes
7 Drop Sensor Connection
Socket
8 Potential Equalization Terminal
9 AC Power Inlet

Information:
• The potential equalization terminal connected to the external
equipotential line to prevent danger caused by the difference in the
potentials between the other devices.

Warning:
 The 12 VDC socket is provided as a customer option.
 The DC power supply has the following specification:
Output voltage: from 12V to 15V; Output current > 1A.
 When the power connector is plugged into the socket, the internal core of the
interface must be the positive electrode, and the outer core the negative
electrode, as indicated by: .

2.3.3 Door opened view

Legend:
1 Door Open Indicator
2 Upper Slot
3 Air Sensor
4 Peristaltic Fingers
5 Door Latch
6 Pressure Sensor
7 Anti-Free Flow Clamp
8 Door Lever
9 Lower Slot

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2.4 User interface

2.4.1 Front panel

The front panel contains all keys and indicators (except for the door open indicator).

Information:
The indicators provide information about the AC power source connection, alarm
priorities and infusion modes, and whether the keyboard is locked or unlocked.

Legend:
1 On/Off
2 KVO Indicator
3 Rate Mode Indicator
4 Increment Up
5 Time Mode Indicator
6 Decrement Down
7 Volume Mode Indicator
8 Start/Pause
9 Keyboard Unlocked Indicator
10 Moves to Next Field; Clears
Alarm; Locks/Unlocks
Keyboard.
11 Changes Infusion Mode;
Silences Alarm.
12 Bolus/Purge
13 Bolus Indicator
14 Clears Infused Volume;
Changes Infusion Mode.
15 Screen
16 AC Power Indicator
17 Alarm Indicator

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2.4.2 Display
The INfusia VP7 displays the following elements on screen to indicate the pump state or infusion
status. The drip chamber symbol is described in the next section.
Symbol Meaning Explanation
Battery Appears at the top right-hand corner of the screen in
3 forms, representing 3 battery operation modes as
described in Section 4.2.2.
Appears at the bottom right-hand corner of the
Real time screen, and indicates the pressure level inside the
occlusion level administration set during infusion. A larger white area
means a higher level of pressure.
When displayed and blinking on the screen, indicates
Infusing
that an infusion or bolus is in progress.
When displayed on the screen, indicates that an
Pause
infusion is paused or the pump is idle.
When displayed and blinking, indicates that the purge
Purge
function is activated.
When displayed and blinking, indicates that the pump
is idle and no action has been taken by the user for
No action
more than 3 minutes. When this symbol is displayed,
the rate value is also blinking.

2.4.3 The drip chamber symbol

The drip chamber symbol is displayed under the battery symbol and next to the text “RATE”. It
takes four forms that indicate different infusion modes and drop sensor states as explained below.

Symbol Explanation
The drop sensor must not be clamped on the drip chamber (volume
mode), there is no infusion in progress, and no drops are falling in the
chamber.
The drop sensor must not be clamped on the drip chamber (volume
mode), but infusion is in progress and there are drops falling in the
chamber.
The drop sensor must be clamped on the drip chamber (rate mode and
time mode), there is no infusion in progress, and no drops are falling in
the chamber.
The drop sensor must be clamped on the drip chamber (rate mode and
time mode), infusion is in progress, and there are drops falling in the
chamber.

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2.5 Drop sensor
The drop sensor detects and counts the drops falling in the drip chamber, and is connected to the
pump via its connection cable.

Legend:
1 Drop sensor case. Contains the infrared emitter and receiver.
2 Drop indicator. This is a LED which flashes once for each drop that falls in the drip chamber.
3 Plug connector. Connects the drop sensor to the pump when plugged into the socket on the back of
device.
4 Sensor clamp. Attaches the drop sensor to the drip chamber.
5 Connection cable. Connects the drop sensor to the plug connector.

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3 Installation

3.1 Global installation

Danger:
Make sure to maintain the appropriate positions between patient, pump,
administration set and container/bottle.

Warning:
 The container must be hung between ~8 to ~20 inches (20 to 50 cm) above the
pump.
 The container must be hung ~2 inches (5 cm) to the right side of the pump.
 Hang the container on one side of the pump, and place the patient on the other
in order to protect the pump and patient from dripping fluids.
 It is recommended not placing the pump higher than ~51 inches (1.3 meter)
above patient.

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3.2 Installing the pump
The INfusia VP7 has a pole clamp on the back for attaching it to a pole or to a secured adapter for
hanging from a cage or stall.
Information:
The pump is designed for installation on a pole with a diameter between ~0.6 to
. ~1.3 inches (15 to 33 mm).

Warning:
It is not recommended to place the pump on a flat table for infusion.

1. Unscrew the clamp (item 1), place

it around the pole (item 2), and
screw the clamp until the pump is
fully secured to the pole.

2. Check that the pump is securely

attached.

Warning:
 Make sure the load bearing capacity of the infusion stand is more than 2.5
times the weight of the device.
 Make sure the infusion stand is positioned securely and stably, and will not
topple over when tilted by up to 20 degrees.

3.3 Loading the administration set

3.3.1 Administration set recommendations

Warning:
 All administration sets loaded on the device should comply with the ISO 8536
Standard.
 The administration sets should be made of PVC with good elasticity.
 Do not use administration sets made with natural rubber latex or silicone.
 The wall thickness of the administration sets should be from ~0.016 to ~0.024
inches (0.4 to 0.6mm).

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  The infrared transmittance of the drip chamber wall must be > 60% for the
drop sensor to work properly.
 Use of administration sets that do not meet the above requirements may cause
incorrect flow rate, broken administration sets, or damage to the device and
injury to the patient.
3.3.2 Loading procedure

Warning:
 Check the integrity of the administration set before use, and make sure the
administration set is not connected to the patient.
 Prepare the solution container and administration set according to your clinical
protocol.

Pull the lever up

1. Close the roller clamp as much as necessary.

2. Open the pump door by pulling the door lever upwards.
3. Open the anti-free flow clamp by pushing its head all the way to the left.
4. Guide the set tubing through the upper slot, the air sensor slot, the peristaltic finger slots, the
anti-free flow clamp and the lower slot.
5. Check that the tubing is straight along the entire path, and correctly secured in the clamp and
the slots.

Information:
You can perform a manual purge at this time to drive out the air in the
administration set.

Warning:
Make sure the roller clamp is open while purging, and closed after the purge is
completed to prevent free flow.

6. Hold the pump door lever, and push the door until it is firmly closed.

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7. Open the roller clamp.

Warning:
 If the brand of the administration set is changed, or the type is changed from 20
d/mL to 60 d/mL or vice versa, the administration set must be calibrated before
use.
 When the administration set or the bottle needs to be replaced, turn the bottle’s
opening upwards to avoid overflow caused by remaining fluid in the bottle.
 Individual set accuracy (after calibration) can range from ± 5 % (over the first
24hr) to ± 10% (from 24hr to 72hr).
 Improved flow rate accuracy can be obtained, from the 24th to the 72nd hour,
by shifting the set segment that is in direct contact with the pumping mechanism
every 24 hours.
 The maximum infusion volume for a single set is 15,000 mL. Overuse of the set
can result in damage and leakage.
 We recommend that the administration set be replaced once every 24 hours of
infusion.
 Stop infusion and close the roller clamp before opening the pump door and
changing the administration set.

3.4 Connecting the drop sensor

Warning:
 The drop sensor is required for all infusion modes except the volume mode.
 An “Error 3” message is displayed if the drop sensor is not connected when
switching on the pump.
 The drop sensor is a light-sensitive device. Avoid exposing the sensor to direct
light during infusion.

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1. Plug the male connector at one end of the drop sensor cable into the female connector located at
the back of the pump.
2. Clamp the drop sensor onto the drip chamber.
3. Check the positioning of the drop sensor on the drip chamber and ensure that:
- The drip chamber is hanging vertically and the drop sensor is clamped horizontally.
- The drip tube of the drip chamber is above the yellow point on the sensor clamp, and the
liquid surface in the drip chamber is below the red point.

Warning:
 Ensure the drip chamber is positioned vertically downward. If it tilts 20 degrees
and the drop sensor detects no drop flow, audio and visual alarms are activated.
 The drop indicator flashes once for each drop falling in the drip chamber
during operation. If the light does not flash or flashes more than once, this may
indicate incorrect installation of or a faulty drop sensor.

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4 Operations

4.1 Electrical connection / disconnection

4.1.1 Electrical connection

Warning:
 Connect the pump to the AC power source with the power cord supplied by
Fresenius Kabi US LLC.
 Position the device in a way that the AC power source remains readily
accessible.
1. Securely install the pump on a pole at patient bedside.
2. Firmly plug the power cord’s appliance connector into the power inlet on the back of the pump.
3. Plug the other end of the power cord into the AC power outlet.

Information:
 The pump does not switch on automatically when connected to an AC power
source.

 To switch on the pump, press and hold the key until the display lights up.
 Once the AC power is connected, the following occur:
- The AC power indicator on the front panel lights up.
- The internal battery begins to charge.

4.1.2 Electrical disconnection

Unplug the power cord to disconnect the AC power source.

Information:
 The AC power indicator switches off when the pump is disconnected from the
AC power source.
 If the pump is on when it is disconnected from the AC power source, it does
not switch off automatically. Instead, the pump switches to internal battery
power.

 To switch off the pump, press and hold the key until the display goes
black.

4.2 Operating on battery

The pump is equipped with an internal rechargeable Li-ion polymer battery in case of disconnection
from mains power. When infusing at a rate of 25 mL/h, the pump’s battery operating time is
typically 8 hours when fully charged.

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 Information:
Before using the pump for the first time, fully charge the battery by connecting the
device to the AC power source for approximately 10 hours without switching it on.

Warning:
The internal battery must be present and connected properly in the pump. If this is
not the case, when connecting to the AC power source and switching on the pump,
the pump activates the “No Battery” alarm (see Section 6.2 in Chapter 6 “Alarms”
for details).

4.2.1 Battery precautions

Danger:
Li-Ion batteries are more sensitive to physical stress. Improper handling of the
pump or battery may cause overheating of the battery, smoke, explosions or fire.
These could result in degraded performance, failure of or damage to the equipment,
or injury to the user.

Warning:
 The battery operating time depends on several factors, one of which is infusion
flow rate. When the “Battery Low” alarm is activated, recharge the battery by
connecting the pump to an AC power source.
 The battery lifespan is 2 years. Contact Fresenius Kabi US LLC for
replacement.
 Do not recharge the battery outside the device, or for more than 24 hours to
avoid overcharging the battery.
 Do not let the battery come into contact with metal objects such as coins, keys
or jewellery, to avoid shorting the battery terminals and causing an accident.
 Do not let the battery get wet. The battery contacts or circuitry could slowly
corrode and pose a safety hazard.
 Do not let the battery get close to areas that may get very hot, such as heaters,
heating appliances, soldering irons or radiators.
 Do not drop, crush, puncture or put a high degree of pressure on the battery, as
this can cause an internal short-circuit and result in overheating.
 Do not use the battery if it is suspected to have been damaged.
 Do not replace with a battery other than that delivered by Fresenius Kabi US
LLC.

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4.2.2 Battery operating mode
When the pump is switched on and operates on battery, the battery symbol is displayed in one of the
following 3 forms, each of which represents one of the 3 battery modes.

Symbol Description Battery mode

One red rectangle, one yellow rectangle and one
Battery is fully charged.
white rectangle.

Battery is low, and “Battery

One yellow rectangle and one white rectangle.
Low” alarm is activated.

Battery is empty, and “Battery

One white rectangle, in a blinking symbol.
Empty” alarm is activated.

When the AC power source is connected, either the charging or the fully charged battery symbol is
displayed.

4.2.3 Battery charging system

The battery charging system is part of the device’s internal circuitry. When the AC power source is
connected, the system charges the battery at a constant voltage, whether the device is switched on or
not. Any problems related to the battery charging system must be serviced by authorised personnel.

4.3 Administration set calibration

Administration set calibration determines the set parameters such as its accuracy in d/mL and
pressure in normal operating conditions.

Warning:
 The administration set must be calibrated before use in the following cases:
- The brand of the administration set is changed.
- The type the administration set is changed from 20 d/mL to 60 d/mL or vice
versa.
If it is not done, the pump will function but with wrong flow settings.
 Make sure the administration set is not connected to the patient before
calibration.

1. Prepare the administration set to be calibrated with the roller clamp closed.
2. Measure and prepare a 100ml of water.
3. Carefully pour the water into the administration set container.
4. Hang the infusion bottle/container on the infusion stand, and install the administration set
securely on the device.
5. Clamp the drop sensor on the drip chamber of the administration set.
6. Open the roller clamp.

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7. Simultaneously press and hold the and keys to switch on the device. The
calibration interface should appear.

Information:
“cali.” is displayed and blinking, and the parameter “IV SET” is not adjustable.

8. Press the key to start calibration.

9. Wait until the container is empty and the device triggers alarms.
10. Press the key to save the calibration results. The device is automatically set to rate
mode.

Information:
After calibration, only the latest administration set information is stored in the
device. The previously stored information is erased.

4.4 Basic operations

4.4.1 Switch on and off

1. Switch on

 Press and hold the key until the display lights up.
 All indicators light up momentarily.
 The device performs a self-test.
 The alarm indicator flashes twice in sequence: first in yellow, then in red.
 An audio tone sounds.

If the self-test is successful, the device will be in pause mode to wait for user's choice of infusion mode
and input.
Information:
When the device is paused, the is displayed, signalling the user to take an
action such as starting the infusion or adjusting infusion parameters. If no action
is taken within 3 minutes, the “No Action” alarm is activated.

If the self-test fails, an error message X (X stands for an error code from 1 to 6 and 20) is
displayed. Contact Fresenius Kabi US LLC immediately.

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2. Switch Off

 Press and hold the key until the display goes black.
Warning:
 The device cannot be switched off when an infusion is in progress.
 Unplug the power cord to avoid the overcharging the battery.

4.4.2 Start or stop infusion

Infusions can be performed in the following modes:
 Rate mode
 Time mode
 Volume mode

Warning:
The drop sensor is used to detect the flow rate, and must be clamped on the drip
chamber for all infusion modes except volume mode.

1. Start infusion

 Simultaneously press and hold the and keys until the desired mode is reached.
 Set the parameters for the selected infusion mode.
 Press the key to start the infusion.
Information:
When infusion is in progress:
- is displayed and blinking.
- “TAR.VOL.” becomes “VOL.INFUSED”, and the associated values change
accordingly.

- The keyboard is locked except for the key.

2. Stop infusion

 Press the key to stop the infusion when infusion is in progress.

Information:
 is displayed when the infusion is stopped.
 After the infusion is stopped,
- You can adjust parameters and resume the infusion.

- The infused volume is not cleared automatically. Press the key to

clear it.

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4.4.3 Rate mode

Information:
In rate mode:
- The drop sensor must be clamped on the drip chamber.
- The flow rate and TAR. VOL. parameters can be set by the user.
- The flow rate is in 2 units: mL/h and d/min.

1. Simultaneously press and hold the and the keys until the rate mode indicator lights
up.
2. Press the key. “RATE” blinks.

3. Use the or key to set the flow rate in “mL/h”.

4. Press the key to change the flow rate unit from “mL/h” to “d/min” if needed.

Information:
When the flow rate setting is too low, you may not be able to change the unit from
“mL/h” to “d/min”.

5. Use the or key to adjust the flow rate in “d/min” if needed.

6. Press the key. “TAR. VOL.” blinks.

7. Use the or key to set the value for volume to be infused.

8. Press the key. “IV SET” blinks.

9. Press the key.

10. Use the or key to set the “IV SET” value according to the loaded administration set.

Information:
 The “IV SET” parameter indicates the d/mL for the administration set.
 This parameter is determined when calibrating the administration set, and is
stored in the pump. The factory default setting is 20 d/mL.
 Adjustment of the “IV SET” value after calibration is not recommended.

Warning:
An incorrect “IV SET” parameter has a negative impact on flow accuracy.

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11. Press the key. “OCCL. LIMIT” blinks.

12. Use the or key to set the occlusion alarm pressure level (H, M or L) as required.

13. Press the key. “VOL.” is displayed and blinks.

14. Use the or key to set the alarm sound level (H, M or L) as needed.

15. Press the key to start the infusion.

Information:
 To adjust the flow rate during infusion, please refer to the “Change flow rate
setting during infusion” section in this chapter.

4.4.4 Time mode

Information:
In time mode:
- The drop sensor must be clamped on the drip chamber.
- The infusion duration (TIME) and TAR. VOL. parameters are set by the user.
- The flow rate is determined by the TIME and TAR. VOL. settings.

1. Simultaneously press and hold the and the keys until the time mode indicator
lights up.
2. Press the key. “TAR. VOL.” blinks.

3. Use the or key to set the value for volume to be infused (VTBI).

Information:
The flow rate value may change along with the VTBI setting.

4. Press the key. “TIME” blinks.

5. Use the or key to set infusion time as required.

Information:
 Infusion time range: from 1min to 1999min.
 The flow rate value may change along with the TIME setting.

6. Press the key. “OCCL. LIMIT” blinks.

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 7. Use the or key to set the occlusion alarm pressure level (H, M or L) as required.

8. Press the key. “VOL.” blinks.

9. Use the or key to set the alarm sound level (H, M or L) as needed.

10. Press the key to start the infusion.

4.4.5 Volume mode

Information:
In volume mode:
- The drop sensor must NOT be clamped on the drip chamber.
- The RATE, TAR.VOL. and ACCURACY ADJUST parameters are set by the user.

1. Simultaneously press and hold the and keys until the volume mode indicator
lights up.
2. Press the key. “RATE” blinks.

3. Use the or key to set the flow rate.

4. Press the key. “TAR.VOL.” blinks.

5. Use the or key to set the value for volume to be infused.

6. Press the key. “ACCURACY ADJUST” blinks.

7. Press the key.

8. Use the or key to set flow accuracy value.

Information:
 The flow accuracy value is measured for the pump and administration set
system.
 Please refer to the Technical Manual for flow accuracy measurement.
 Accuracy adjustment range: -50% to +50% (in 1% increments).
 An example of setting the “ACCURACY ADJUST” value:
- If the displayed infused volume is greater by 5% than the actual infused
volume, the flow accuracy value must be set to 5%, and vice versa.
9. Press the key. “OCCL. LIMIT” blinks.

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 10. Use the or key to set the occlusion alarm pressure level (H, M or L) as required.

11. Press the key. “VOL.” blinks.

12. Use or key to set the alarm sound level (H, M or L) as needed.

13. Press the key to start the infusion.

4.4.6 Bolus setup and function

1. Bolus setup

 Press the key to switch on the device.

 Simultaneously press and hold the and keys until the bolus indicator lights up.
 The “RATE” parameter blinks.
 Use the or key to set the bolus flow rate.

 Press the key. “TAR.VOL.” blinks.

 Use the or key to set the bolus volume to be infused.

Information:
 Bolus volume range: from 1 to 100 mL.

 Press the key to save the settings, and exit the bolus setup mode.

2. Start/stop bolus function

Information:
 Bolus function is performed manually.
 A bolus is delivered at a preset bolus rate ( from 1 to 1200mL ) until it is
stopped or the target bolus volume is reached.

 Start infusion in one of the modes.

 Press and release the key.

 Immediately press and hold the key again to start bolus.

 Keep pressing the key as long as you want the bolus to last.

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 Information:
After bolus function has started, the following are true:
- is displayed and blinking.
- The bolus indicator lights up and blinks.
- A pre-set bolus flow rate is displayed in the place of normal flow rate.

 Release the key to stop the bolus function and resumes the prior infusion.

Information:

 The bolus continues as long as the key is pressed and held, as long as no
alarms are triggered and the target bolus volume limit has not been reached. .
 If the bolus reaches the target bolus volume, the device stops the bolus function
and resumes the prior infusion. The audio alarm tone also sounds twice.
 The total infused volume includes the bolus volume.
 The bolus rate resumes its default value when the device is restarted.
- When the maximum speed is ≥1000ml/h, it resumes its default value of
1000ml/h.
- On the contrary it resumes its default value of the maximum speed.

4.4.7 Purge

Information:
 The purge function drives air out of the administration set quickly.
 When purge function is activated, the “Air-in-Line” alarm is disabled.

Warning:
 Ensure the infusion is stopped before starting the purge function.
 Make sure the administration set is not connected to the patient during purging.
 When an occlusion occurs in the administration set, do NOT start the purge
function. Instead, perform purge manually.

 Pause the infusion. is displayed.

 Press and release the key. is displayed.

 Immediately press and hold the key to start the purge.

Information:
After the purge is started:
- is displayed and is blinking.
- The purge continues at the factory default flow rate of 600mL/h.

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 Release the key to stop the purge function and return the device to the paused state.

4.4.8 KVO (Keep Vein Open)

When the infused volume reaches the target volume during infusion, the normal flow rate
automatically switches to the KVO rate.
Information:
 KVO rates:
- 1 mL/h for flow rates ≤10 mL/h.
- 3 mL/h for flow rates >10 mL/h.
 After KVO is started, the following are true:
- The medium-priority “Infusion Complete” is activated.
- The KVO indicator blinks.

The KVO continues until the key is pressed, or until it is interrupted by a high priority alarm.

4.4.9 Change flow rate setting during infusion

Information:
This function is available only when infusion is in rate mode.

 Start infusion in rate mode.

 Press the key once to unlock other keys. The keyboard unlocked indicator lights up.

 Use the or key to adjust the flow rate according to clinical requirements.

 Press the key within 2 seconds. The device beeps twice and the adjustment takes effect.

Information:
 The keyboard is locked again and keyboard unlocked indicator goes off.
 Before the device beeps and the flow rate adjustment takes effect:
- If any alarm occurs (except for “Low Battery” and “Key Stuck During
Infusion”), the flow rate returns to the previous setting.
- If the bolus function is running, the new flow rate will take effect when bolus
ends.

- If the key is pressed, the flow rate returns to the previous setting.

 If the flow rate is adjusted and the key is not pressed within 2 seconds,
the flow rate reverts to its previous value and the device beeps twice.

 To lock the other keys, press the key again. If no any action is taken for

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 over 30 seconds, the keyboard is locked automatically, and the keyboard
unlocked indicator switches off.

4.5 History records

Information:
The device can store the 5000 most recent infusion and alarm history events only for
export.

4.5.1 Export history logs

Information:
If it is necessary to export logs, please contact Fresenius Kabi US LLC for the
required data communication software.

4.5.2 Set date and time

Information:
The time and date are used only in history records.

 Simultaneously press the and keys at the to switch on the device. Wait until “C-1”
is displayed and blinking.
 Press the key and “C-2” is displayed and blinking. The numbers displayed under “C-2”
show the time in hours and minutes.
 Press the key, so that the “hour” number blinks.

 Use the or key to set the hour.

 Press the key, so that the “minute” number blinks.

 Use the or key to set the minute.

 Press the key so that “C-2” blinks again.

 Press the key, so that “C-3” is displayed and blinking. The numbers displayed under “C-3”
show the date.
 Press the key, so that the “month” blinks.

 Use the or key to set the month.

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 Press the key, so that the “day” blinks.

 Use the or key to set the day.

 Press the key, so that the “year” blinks.

 Use the or key to set the year.

 Press the key, so that “C-3” blinks again.

 Press and hold the key to switch off the device. The new settings for time and date will
take effect when the device is switched on again.

4.6 Software version check

 Simultaneously press the and the keys to switch on the device. Wait until “C-1” is
displayed and blinking.
 The number displayed under “C-1” is the software version.
 Press and hold the key to switch off the device.

4.7 Device reset

Information:
The device needs to be reset when the control of the device cannot be restored by
any other means, for example, the device cannot be switched off.

 Insert thetip of a pointed object, such as a

straightened paper clip, into the reset hole
near the AC power inlet.
 Push it in as far as possible, until the display
goes black.

Warning:
Contact Fresenius Kabi US LLC
if the reset does not work and the
device continues to malfunction.

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5 Cleaning and disinfecting

The device must be cleaned after each use, and before maintenance. Only disinfect the device after
it has been cleaned, and only when appropriate.

Recommended agent for cleaning: locally available multi-enzymatic cleanser or detergent.

Recommended agent for disinfecting: 10% household bleach in water (produces 0.55% Sodium
Hypochlorite).

5.1 Prohibited cleaning and disinfecting agents

The following agents are prohibited for use in cleaning or disinfecting:
 Full strength bleach
 Trichloroethylene
 Abrasive detergents
 Undiluted alcohol

Use of these aggressive agents may damage the plastic parts of the device and cause it to
malfunction.

5.2 Precautions for cleaning

Warning:
 The device must only be cleaned and disinfected by trained staff.
 Switch off the device, and disconnect the power cord from the AC power source
before cleaning. Disconnect all other cables.
 Verify that the RS232 and other connectors are properly covered.
 Do not autoclave or use steam sterilisation.
 Do not clean in a dishwasher or shower.
 Carefully read and follow the instructions on the container of each cleaning and
disinfecting agent.

5.3 Cleaning and disinfecting guidelines

1. Prepare both cleaning and disinfecting solutions.
2. Wet a piece of disposable cloth with the cleaning solution and carefully wring it out.
3. Wipe the least exposed case and panel surfaces, then the most exposed surfaces, the most
critical zones and the mains power cord.
4. Repeat the steps 2- 3 with a fresh piece of cloth wetted with water.
5. Wet a piece of disposable cloth with the disinfectant solution and carefully wring it out.
6. Repeat steps 3 - 4.

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6 Alarms
INfusia VP7 Infusion Pump immediately activates audible and visual alarm signals when an alarm
condition ends.

Warning:
 When an alarm is activated, first clear the alarm, then check and respond to the
cause of the alarm.
 Restart the device only after the corrective action has been taken.

6.1 Alarm information

Visual signal
Alarm Priority Audio signal
Indicator Message displayed

Rate Abnormal H Red Y

(blinking)
Door Open H Red Y

Air-in-Line H Red Y

Occlusion H Red Y

Bottle Empty H Red Y

Battery Empty H Red Y

(blinking)

No Battery H Red Y
20
Free Flow H Red Y
8
Key Stuck During
H Red Y
Infusion 9
Key Stuck During Pause M Yellow Y
9
Infusion Complete M Yellow Y

No Action L Yellow (blinking) Y

Low Battery L Yellow / Y

Information:
 The device stops infusion and triggers audio and video alarm signals when a
high or medium priority alarm occurs.

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  The device automatically enters KVO mode when the “Infusion Complete”
alarm is activated.

6.2 Alarm conditions and corrective actions

Alarm Alarm condition Corrective actions

Rate Abnormal The drop sensor does not detect any drop in a Check the drop sensor.
certain time or detects abnormal drop rate, or
overflow or underflow occurs.
Door Open The pump door is open during infusion. Close the pump door.
Air-in-Line Air bubbles are detected in the administration Drive the bubble out of the
set. administration set.
Occlusion Pressure inside the administration set reaches a Release the pressure in the
certain level (H, M or L) during infusion. administration set.
Bottle Empty The infusion bottle is empty. Replace the bottle or end
the infusion.
Battery Empty The remaining battery operating time is less than Connect the device to an
3 minutes. AC power source.
No Battery No battery or the battery is dead. Contact the manufacturer.
Free Flow Unintended or uncontrolled infusion flow Check the administration
occurs. set.
Key Stuck During A key is stuck or is held for over 5 seconds or Check and release the
Infusion/ Pause two or more keys are pressed at the same time key(s).
during infusion or pause.
Infusion Complete Infused volume reaches the target volume. End the infusion.
No Action Device is switched on but no action is taken by Start infusion or switch off
the user for over 3 minutes. the device.
Battery Low The remaining battery operating time is less than Connect the AC power
30 minutes. source.

Information:
 In addition to the actions suggested above, see Chapter 7 “Troubleshooting” for
more troubleshooting solutions.
 For the “Battery Empty” alarm, if the power loss is less than or equal to 30
seconds, the alarm settings prior to the power loss are restored automatically.
 When the “Infusion Complete” alarm is triggered, the device automatically
switches to KVO. When the alarm is cleared, the target volume is set to 0 mL
automatically.
 The maximum delivery volume caused by a single fault condition (for example,
drop sensor anomaly) is less than 1.5 mL.

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6.3 Intelligent alarm system
If multiple alarm conditions occur at the same time, the intelligent alarm system prevents a lower
priority alarm condition from generating alarm signals when a higher priority alarm condition
occurs. In other words, the device only generates signals for the alarm with the highest priority.
When alarms with the same priority occur at the same time, the device responds according to the
following alarm logic.

Alarm priority Logic

“No Battery” comes before “Empty Battery”.
“Battery Empty” comes before “Air-in-Line”.
“Battery Empty” comes before “Door Open”.
“Battery Empty” comes before “Occlusion”.
High
“Battery Empty” comes before “Free Flow”.
“Battery Empty” comes before “Bottle Empty”.
“Battery Empty” comes before “Rate Abnormal”.
“Battery Empty” comes before “Key Stuck During Infusion”.

6.4 Features of alarm signals

Alarm priority Visual signal Audible signal

 Alarm indicator lights up in red.  5 tones, repeat.
High  Cycle: 500 ms.
 The alarm message is displayed.
 Alarm indicator lights up in yellow.  3 tones, repeat.
Middle  Cycle: 2 s.
 The alarm message is displayed.
 Alarm indicator lights up in yellow.  2 tones, cycle: 20s.
Low  The indicator remains steadily lit.
 The alarm message is displayed.

Information:
If the “Battery Empty” alarm is activated, the battery symbol also flashes on the
display.

6.5 Alarm silence

 Press the key to silence an audible alarm.

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 Information:
 The following alarms cannot be silenced: “Key Stuck During Infusion / Pause”，
“Low Battery”, “Battery Empty” and “No Battery”.
 All visual signals, including the indicator and the displayed message, remain
visible when an audible alarm is silenced.

 A silenced audible alarm resumes either in 110 seconds, or if the key is

pressed again.

6.6 Alarm dismissal

 Press the key to dismiss an active alarm.

Warning:
After an alarm is dismissed, the infusion remains stopped, and the audible and visual
signals disappear. However, the alarm’s cause must still be found and corrected.

Information:
The following alarms cannot be dismissed: “Key Stuck During Infusion / Pause”，
“Low Battery”, “Battery Empty” and “No Battery”.

6.7 Volume of audible alarm signals

 High priority alarm signals are louder than or equal to medium priority alarm signals, which are
in turn louder than or equal to low priority alarm signals.
 In a particular set of audible alarm signals, high priority signals convey a higher level of
urgency than low priority and informational signals.
 Similarly, medium priority signals convey a higher level of urgency than low priority and
informational signals.

6.8 Maximum alarm delay

For all alarms, the time between the alarm condition and the alarm signals is less than 5 seconds.

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7 Troubleshooting

Information:
Some entries in the Troubleshooting Guide and Error Messages may involve
technical details for service technicians.

7.1 Troubleshooting guide

Trouble Possible causes Corrective actions

 Check battery connection wires.
Battery or battery connection
 Replace battery wires.
wires are disconnected.
 Replace battery.
 Check power supply board
connection wires and main board.
Power supply board connection  Check switching power supply
wires are disconnected, or main board.
board is defective.  Replace power supply board
The device cannot connection wires.
be switched on with  Replace main board.
its internal battery,  Check drop sensor cable.
or when the AC Drop sensor or its connection  Check drop sensor.
power source is cable is shorted.  Replace drop sensor cable.
connected. The AC  Replace drop sensor.
power indicator does  Check audio board connection
not light up. wires.
Audio board or its connection  Check audio board.
wires are shorted.  Replace audio board connection
wires.
 Replace audio board.
 Check air detection board.
 Check connection wires between
Air detection board or its
air detection board and main board.
connection wires are shorted.
 Replace air detection board.
 Replace connection wires.
 Check motor speed detection
Motor speed detection board is board.
defective.  Replace motor speed detection
board (181 board).

Display board is shorted, or  Check display board and key.

 Check display module.
key is disconnected.  Replace display board.
 Replace display module.

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  Check reset board.
 Check reset board connection
Reset board and its connection
wires.
wires are shorted, or reset key is
 Check reset key.
shorted.
 Replace reset board.
 Replace reset key.

 Check fuses.
Fuses are burnt out, or live line  Check live line and null line
and null line are not connected. connections.
 Replace fuses.

No sound, or
abnormal sound for  Check speaker connection wires.
Speaker is defective, or speaker
alarms or  Check speaker.
connection wires are not
key-pressing when  Replace speaker.
connected.
device is switched  Replace speaker connection wires.
on.
 Check the device door.
Device door is not closed.
 Close the door.
“Door Open” alarm
is activated when the Door sensor (reed switch) is  Check reed switch.
device is switched defective.  Replace reed switch.
on.
 Check the magnet.
Magnet falls off the device door.
 Reinstall the magnet on the door.
“Air-in-Line” alarm
 Administration set is not  Check administration set.
is activated, but no
installed properly.  Check air detection board.
air bubbles are
 Air detection board is  Replace air detection board.
found in
defective.  Reinstall administration set.
administration set.
 Check fuses.
 Test live line and null line
Fuses are burnt out. connections.
AC power indicator  Replace fuses.
does not light up.  Reconnect live line and null line.
 Check AC power indicator.
AC power indicator is damaged.
 Replace AC power indicator.

Alarm indicator  Check alarm indicator.

Alarm indicator is damaged.
does not light up.  Replace alarm indicator.

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  Check main board.
Main board is defective, or P7
 Check P7 connector on main
connector on main board is
board.
badly connected.
 Replace main board.
 Check AC power source
AC power source is badly
connection.
connected.
Display does not  Reconnect AC power source.
show recharging  Check switching power supply
battery when AC module.
power source is Switching mode power supply is  Check fuses.
connected. defective, or fuses are burnt out.  Replace switching power supply
module.
 Replace fuses.
 Check display FPC connector.
Display does not Display is badly connected.  Check display FPC.
show anything, or  Replace FPC and connector.
shows distorted
 Check display board.
contents. Display board is defective.
 Replace display board.
 Check drop sensor.
Drop sensor is defective.
 Replace drop sensor.
“Rate Abnormal” is  Check stepper motor.
displayed when  Check main board.
Motor does not turn.
 Replace motor.
key is pressed.  Replace main board
Administration set is damaged  Check administration set.
or broken.  Replace administration set.

“Occlusion” is  Check pressure sensor.

Pressure sensor is defective.
displayed when  Replace pressure sensor.

 Test main board.

key is pressed. Main board is defective.
 Replace main board.
 Check battery.
Battery is defective.
“Battery Low”  Replace battery.
alarm is activated  Check power supply board.
Power supply board or
when AC power  Check switching power supply
switching power supply is
source is connected. module.
defective.
 Replace power supply board.

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  Check fuses.
 Check live line and null line
Fuses are burnt out, or AC
connection.
power live line and null line are
 Replace fuses.
disconnected.
 Reconnect or replace live line and
null line.
 Check main board.
Main board is defective.
 Replace main board.
Export software is not properly  Check PC software version.
installed on PC.  Update PC software.
The wrong communication port  Check PC communication port.
is selected by the software.  Select a different port.
History records PC and RS232 port on device is  Check cable that connects device
cannot be exported. badly connected or to PC communication port.
disconnected.  Reconnect or replace cable.

 Check main board.

Main board is defective.
 Replace main board.

Display shows
 Check main board.
invalid time, or time Main board is defective.
 Replace main board.
is shown as 00:00.

7.2 Error messages

Information:
Error messages include switch on and operational self-test failure messages, and
alarm messages displayed as text or symbols.

Message displayed Possible causes Corrective actions

1. Check EEPROM
EEPROM (24LC1025) self-test
(24LC1025).
1 error.
2. Replace EEPROM.
1. Check audio board
connection wires.
Audio board self-test error
2. Check audio board.
2
3. Test speaker.
1. Check drop sensor control
board.
Drop sensor self-test error 2. Check cable that connects
3 drop sensor to device.
3. Check drop sensor cable plug

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 and socket.
1. Check pressure sensor.
2. Check RV1 potentiometer on
main board.
3. Adjust voltage at point T2 on
4 Pressure sensor self-test error
main board to 200 mV by
adjusting RV1.
4. Check pressure sensor and its
connection wires.
1. Check air sensor.
2. Check P11 connector on main
board.
3. Check air detection board
Air sensor self-test error
5 connection wires.
4. Check connection between air
detection head and air
detection board.
1. Pressure accuracy is not
Pressure calibration error.
calibrated.
6
“No Battery” error or alarm.
1. No battery in the device. 1. Check battery connection
2. The battery is dead. wires.
20
3. The battery is badly 2. Check battery connector.
connected. 3. Check battery.
“Battery Empty” alarm
1. Fuses are burnt out. 1. Check or replace fuses.
(blinking) 2. Switching power supply 2. Check or replace switching
module is defective. power supply module.
“Door Open” alarm.
1. Close pump door.
1. Pump door is open.
2. Check door sensor.
2. Door sensor (reed switch) is
3. Check door magnet.
defective.
4. Replace door sensor.
3. Door magnet falls off.
5. Reinstall door magnet.
“Air-in–Line” alarm.
1. Air bubbles are found in 1. Purge administration set.
administration set. 2. Check air sensor.
2. Air sensor is defective. 3. Replace air sensor.
“Occlusion” alarm.
1. Refer to Section 6.2 and
1. Refer to Section 6.2 and
Section 7.1 for corrective
Section 7.1 for possible
actions.
causes.
“Bottle Empty alarm. 1. Check and replace IV bottle,

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 1. IV bottle is empty. or stop infusion.
2. Drop sensor is not installed 2. Check and reinstall drop
properly. sensor.
3. Drop sensor is defective. 3. Replace drop sensor.
Rate abnormal alarm.
1. Refer to Section 6.2 and
/ 1. Refer to Section 6.2 and
Section 7.1 for corrective
(blinking) Section 7.1 for possible causes.
actions.
Free flow alarm.
1. Check and reinstall
1. Administration set is not
8 administration set.
installed properly.
Key stuck during infusion/pause
alarm. 1. Check keyboard.
9
1. One or more keys are broken. 2. Replace keyboard.
Infusion complete alarm.
1. Infused volume reaches target 1. End infusion.
volume.
No Action alarm.
1. Device is switched on, but no 1. Start infusion, or switch off
action is taken by the user for device.
3 minutes.
Battery low alarm. 1. Refer to Section 6.2 and
/ 1. Refer to Section 6.2 and Section 7.1 for corrective
Section 7.1 for possible causes. actions.

Warning:
If the above troubleshooting measures do not guide you to solve the problem,
please contact Fresenius Kabi US LLC immediately.

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8 Technical Information

8.1 Performance

8.1.1 Infusion flow rate

Range: 1.0 to 1200 mL/h, or 1 to 400 d/min,
Increments: 0.1 mL/h (from 1.0 to 99.9 mL/h)
1 mL/h (from 100 to 1200 mL/h)
or 1 d /min
Accuracy: ±5% total accuracy over a period of 24h with a maximum infusion of 1 litre in
accordance with EN/IEC 60601-2-24

Warning:
Flow rate accuracy can be influenced by administration set configuration, fluid
viscosity, and fluid temperature.

8.1.2 Volume to be infused

Range: 0.0 to 9999 mL
Increments: 1 mL

8.1.3 Infusion time

Range: 1 to 1999 min
Increments: 1 min

8.1.4 Purge rate

600 mL/h

8.1.5 Bolus rate

Range: 1 to 1200 mL/h
Increments: 0.1 mL/h for flow rate < 100 mL/h
1 mL/h for flow rate ≥ 100 mL/h

8.1.6 Bolus volume to be infused

Range: 1 to 100mL
Increments: 1mL

8.1.7 KVO rate

1 mL/h for infusion flow rate ≤ 10 mL/h
3 mL/h for infusion flow rate > 10 mL/h

8.1.8 Occlusion alarm pressure level

High (H): ≤1125 mmHg (≤ 150 kPa)
Medium (M): ≤750 mmHg (≤ 100 kPa)

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 Low (L): ≤450 mmHg (≤ 60 kPa)

8.1.9 Occlusion alarm response time

Flow rate Occlusion alarm level Alarm response time

High ≤ 3h
1 mL/h
Low ≤ 2h
High ≤ 5min
25 mL/h
Low ≤ 5min

Information:
 Occlusion alarm response times vary according to the device and the
administration set.
 The maximum occlusion pressure in the administration set generated by the
device is 1875 mmHg (250 kPa).
 When an occlusion alarm occurs, the anti-bolus function is automatically
started to reduce the amount of bolus generated by the occlusion.

8.1.10 Bolus volume at occlusion release

Flow rate Occlusion alarm level Bolus volume

High ≤ 1.5 mL
1 mL/h
Low ≤ 0.6 mL
High ≤ 1.5 mL
25 mL/h
Low ≤ 0.6 mL

8.2 Technical characteristics

8.2.1 Operation mode

The pump is designed for continuously delivery of intravenous infusion.

8.2.2 Power supply specifications

The wall plug must be connected directly to the mains power socket.
Power source 100V - 240V, 50/60Hz, earthed
Fuses 2 × F2AL/250V
AC Power
Maximum consumption 35 VA
Power cord length 118 inches (3 m)
External DC power supply （user option） 12V-15V / Power >15 W

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8.2.3 Battery specifications

Characteristics 11.1VDC, 2000mAh -Li-ion polymer battery

Weight Approximately 0.26 lbs (120 g)
Battery operating time At an infusion rate of 25 mL/h, the battery operating time is typically 8
hours when fully charged.
Battery recharge time Pump OFF: < 10 h, Pump ON: < 14 h

8.2.4 Power consumption

Typical power consumption of the pump in standard operating conditions: < 10W.

8.2.5 Sensitivity of Air Sensor

50μL.

8.2.6 Dimensions – Weight

Weight Dimensions (H x W x D)
Pump 4.4 lbs (2 kg) 9.1 x 4.9 x 4.9 inches (230 × 125 × 125mm)
excluding pole clamp protrusion
Packaging 6 lbs (2.7 kg) 11.8 x 10.2 x 6.3 inches (300 × 260 × 160mm)

8.2.7 Compliance with standards

Safety of Electro Compliant with standards： IPX4  Protection against splashing

Medical  EN/IEC 60601-1 liquid
Equipment  EN/IEC 60601-2-24  Protection against leakage
 EN/IEC60601-1-8 current: type CF applied part
 IEC 60529:2001  Protection against electric
shocks: class I
EMC Compliant with standards：
(ElectroMagnetic  EN/IEC 60601-1-2/AC2010  NRTL mark
Compatibility)  EN/IEC 60601-2-24

8.3 Start-up and Trumpet Curves

The start-up curve represents the change in flow rate over a period of time, and the trumpet curve
shows the variations of the mean flow accuracy over specific periods of observation.

The following graphs are obtained from tests performed with a system consisting of INfusia VP7
Infusion Pump and Fresenius Kabi Infudrop® Air 21P administration sets. The fluid used is
distilled water.

These tests were conducted in accordance with IEC60601-2-24 requirements.

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The results may not align closely with those obtained in clinic because of the variations in
administration sets, physical properties of infused fluid, the environment, and so on. The error in
flow accuracy caused by such variations may be larger than 5%, as specified in Section 8.1.1
Infusion flow rate.

8.3.1 Start-up curves

 Flow rate: 25 mL/h

 Flow rate: 1 mL/h

8.3.2 Trumpet curves

 Flow rate: 25 mL/h, the second hour

 Flow rate: 25 mL/h, the last hour

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 Flow rate: 1 mL/h, the second hour

 Flow rate: 1 mL/h, the last hour

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9 EMC Declaration
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT
AND SYSTEMS

1 Guidance and manufacturer´s declaration – electromagnetic emission

The INfusia VP7 Infusion Pump is intended for use in the electromagnetic environment specified below.
2 The customer or the user of INfusia VP7 Infusion Pump should assure that it is used in such an
environment.
3 Emissions test Compliance Electromagnetic environment - guidance
The INfusia VP7 Infusion Pump uses RF energy only for its internal
RF emissions
4 Group 1 function. Therefore, its RF emissions are very low and are not likely
CISPR 11
to cause any interference in nearby electronic equipment.
RF emissions
5 Class B
CISPR 11
Harmonic
6 emissions Class A The INfusia VP7 Infusion Pump System is suitable for use in all
IEC 61000-3-2 establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that
Voltage
supplies buildings used for domestic purposes.
fluctuations /
7 Compliant
flicker emissions
IEC 61000-3-3

Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT

and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
The INfusia VP7 Infusion Pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the INfusia VP7 Infusion Pump should assure that it is used in such an environment.
Compliance
Electromagnetic environment -
Immunity test Test level level
guidance
60601-2-24

Electrostatic Floors should be wood, concrete or ceramic tile. If

± 8 kV contact ± 8 kV contact
discharge (ESD) floors are covered with synthetic material, the relative
± 15 kV air ± 15 kV air
IEC 61000-4-2 humidity should be at least 30%.

± 2 kV for power
± 2 kV for
supply lines
Electrostatic power supply
Mains power quality should be that of a typical
transient / burst lines
± 1 kV for commercial or clinical setting.
IEC 61000-4-4
input/output
lines

Surge ± 1 kV ± 1 kV Mains power quality should be that of a typical

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 differential differential commercial or clinical setting.
IEC 61000-4-5 mode mode

± 2 kV common ± 2 kV common
mode mode
< 5% UT (>95% < 5%UT (>95%
dip in UT) for 0.5 dip in UT) for
cycle 0.5 cycles
Voltage dips,
short 40% UT (60% dip 40% UT (60% Mains power quality should be that of a typical
interruptions in UT) dip in UT) commercial or clinical setting. If the user of the
and voltage for 5 cycles for 5 cycles INfusia VP7 Infusion Pump requires continued
variations on operation during power mains interruptions, it is
power supply 70% UT (30% dip 70% UT (30% recommended that the INfusia VP7 Infusion Pump be
input lines in UT) dip in UT) powered from an uninterruptible power supply or a
for 25 cycles for 25 cycles battery.
IEC 61000-4-11
< 5% UT < 5% UT (>95%
(>95% dip in UT) dip in UT) for 5
for 5 sec sec
Power
frequency Power frequency magnetic fields should be at levels
(50/60 Hz) 400 A•m 400 A•m characteristic of a typical location in a typical
magnetic field commercial or clinical setting.
IEC 61000-4-8

NOTE: UT is the AC mains voltage prior to application of the test level.

Guidance and manufacturer´s declaration – electromagnetic immunity – for

LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
The INfusia VP7 Infusion Pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the INfusia VP7 Infusion Pump should assure that it is used in such an environment.
Compliance
Immunity
Test level level Electromagnetic environment - guidance
test
60601-2-24

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 Portable and mobile RF communications equipment should be used
no closer to any part of the INfusia VP7 Infusion Pump, including
cables, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
3.5
d=[ ]√𝑃
Conducted 3 Vrms [V1]V 𝑉1
RF 150 kHz to
IEC 80 MHz
61000-4-6 outside ISM
bandsa 12
d=[ ]√𝑃
𝑉2
10 Vrms [V2]V
150 kHz to
80 MHz
within ISM
bandsa 12
d=[ ]√𝑃 80MHz to 800MHz
𝐸1
Radiated RF 10 V/m [E1]V/m 23
d=[ ]√𝑃 800MHz to 2.5 GHz
IEC 80 MHz to 𝐸1
61000-4-3 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 survey c should be less than the compliance
level in each frequency range. d
Interference may occur in the vicinity of equipment marked with the
following symbol:

NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic is affected by absorption and
reflection from structures, objects and people.

a) The ISM (industrial, scientific and medical) bands between 150 kHz 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 40.70 MHz
b) The compliance levels 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.
c) 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 theoretically predicted

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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 INfusia VP7 Infusion
Pump is used exceeds the applicable RF compliance level above, the INfusia VP7 Infusion Pump should be
observed in order to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the INfusia VP7 Infusion Pump.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Recommended separation distances between portable and mobile RF communications

equipment and the EQUIPMENT or SYSTEM -for LIFE-SUPPORTING ME EQUIPMENT
and ME SYSTEMS
Recommended separation distances between
portable and mobile RF communications equipment and the INfusia VP7 Infusion Pump
The INfusia VP7 Infusion Pump is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the INfusia VP7 Infusion Pump can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the INfusia VP7 Infusion Pump as recommended below,
according to the maximum output power of the communication equipment.
Separation distance [m] according to frequency of transmitter
Rated
maximum 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5 GHz
output of outside ISM bands within ISM bands MHz bb
transmitter 12
3.5 d = [ V ]√P 12 23
[W] d = [ 𝑉 ]√𝑃 2 d = [ 𝐸 ]√𝑃 d = [ 𝐸 ]√𝑃
1 1 1

0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.73

1 1.2 1.2 1.2 2.3

10 3.8 3.8 3.8 7.3

100 12 12 12 23

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 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz 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 40.70 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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10 Device Storage and Transport
If the device is not used for an extended period of time, it is recommended that the device be stored
in an area that is clean, organised and compliant with the storage conditions below.

10.1 Storage and transport conditions

Warning:
Please store or transport the device according to the specified transport and
storage conditions.
o Temperature range: 14°F to 131°F (-10°C to +55°C).
o Pressure range: 645 mmHg to 795 mmHg (860 hPa to 1060 hPa).
o Humidity range: 20% to 90%, no condensation.

10.2 Preparing for storage

 Switch off the device and remove the administration set.

 Connect to an AC power source to recharge the battery.
 Disconnect the power cord and all other cables.
 Remove the pump from the mounting pole.
 Clean and disinfect the pump and the drop sensor.
 Carefully handle the device, and store it in an area specially prepared for storage.

Warning:
If the device will be stored for a very long time, connect it to an AC power source
every one (1) month to recharge the battery.

10.3 Using after storage

Warning:
After storage or transport, do the following before using the device:
1. Connect the device to an AC power source to recharge the battery for about 10
hours without switching the device on.
2. Test the device’s functioning, and check it for traces of damage, especially
after transport.

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11 Services

11.1 Maintenance

Warning:
 Maintenance procedures are intended to be performed only by qualified
personnel.
 It is recommended that preventive maintenance is carried out once per year.

Information:
If PCB diagrams, intervention procedures, test procedures, spare parts lists, and
other technical information are needed for maintenance, please contact Fresenius
Kabi US LLC.

11.1.1 Regular inspections

To ensure that the pump remains in good operating condition, regular inspections are required each
time the pump is used.

Warning:
Failure to perform these inspections can result in improper device operation.

Procedure Requirements
1. Front & rear cases  No obvious damage, burrs, deformations or scratches are
seen on external surfaces.
 The two cases are closed and fit together perfectly.
2. Pump door and lever  No obvious damage, burrs, deformations or scratches are
seen on external surfaces.
 The door is easily opened or closed with no abnormal
noise.
 The door fits well into the front case.
 The door lever can be operated properly, and the door
cannot be opened without lifting the lever.
 The door and lever do not appear loose.
3. Display screen  No obvious damage, deformations or scratches are seen on
the external surface.
 Texts and symbols are displayed clearly and completely
with no tilted, deformed or missing contents.
4. Keyboard  No obvious damage is seen on the external surface.
 Keys are easily pressed and released without getting stuck.
5. Pole clamp  No obvious damage is seen.
 It can be operated properly without resistance or the need to

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 apply extra force.
 The pole clamp screw is still functioning well.
6. Anti-free flow clamp  No obvious damage is seen.
 It can be easily opened or closed with no abnormal noise.
7. RS232 port  It is firmly installed on the rear case.
 Screws and nuts are not loose, damaged or rusted.
8. Potential equalisation  It is firmly installed on the rear case.
terminal  It is not damaged or rusted.
9. AC power inlet  It is firmly installed on the rear case.
 The power cord can be plugged in easily and securely.
10. Drop sensor  No obvious damage is seen on external surfaces.
 The cable is properly connected to the sensor and the plug
connector.
 It can be plugged into the socket securely.

11.1.2 Battery
The device contains a rechargeable lithium-ion polymer battery which recharges automatically when
the device is connected to the AC power source. The initial full battery charge (before switching on
the pump for the first time) takes about 10 hours.
To avoid overcharging the battery, please switch off and disconnect the device from the AC power
source after 24 hours to avoid overcharging when the pump is not being used.
It is necessary to recharge the battery if the device is stored for more than one month.

Please contact Fresenius Kabi US LLC for a replacement battery. The old battery should be
handled according to local laws.

11.1.3 Fuses
When the fuses need to be replaced, please contact Fresenius Kabi US LLC.

11.1.4 Drop sensor

The drop sensor is a sensitive component. If the device is often found to be operating at an incorrect
flow rate for no apparent reason, or if the “ERROR 3” alarm is constantly triggered, do the
following:

 Check the drop sensor to ensure it is installed properly.

 Switch on the device.
 Remove the drop sensor, and press the clamp to open the drop sensor.
 Move your index finger up and down inside the drop sensor to simulate drops falling through
the drop sensor. For each finger movement, the indicator should flash once. Otherwise, the drop
sensor is defective.

If this check does not resolve the problem, contact Fresenius Kabi US LLC for more information.

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11.1.5 Device service life
To ensure the safety of medical equipment, the service life for the device is 7 years after the
production date. Use of expired products may cause damage to patients and healthcare staff.

The electronic memory storage time of the device after switching off is 20 years.

11.1.6 Disposal
 Expired devices, removed batteries, and used needles and administration sets
must be disposed of according to your local laws on electronic and medical
waste.
 Improper management of expired devices, removed batteries, and used needles
and administration sets can contaminate environments and pose a health risk
to the public and waste workers.

11.2 Warranty

11.2.1 General warranty conditions

Fresenius Kabi US LLC guarantees that this product is free from defects in material and
workmanship during the period defined by the accepted sales conditions, except for batteries and
accessories.

11.2.2 Limited warranty

To benefit from the materials and workmanship guarantee from Fresenius Kabi US LLC, make sure
to observe the following conditions:
 The device must have been used according to the instructions described in this IFU and other
accompanying documents.
 The device must not have been damaged whilst being stored or repaired, and must not show
signs of improper handling.
 The device must not have been altered or repaired by non-qualified personnel.
 The internal battery of the device must not have been replaced by a battery other than that
specified by the manufacturer.
 The serial number (ID/N°) must not have been altered, changed or erased.

Information:
 If one or more of these conditions have been violated, Fresenius Kabi US
LLC will prepare a repair estimate covering all required parts and labour.
 To repair or return a device, please contact Fresenius Kabi US LLC.
11.2.3 Warranty conditions for battery and accessories
Batteries and accessories may have specific warranty conditions. Please contact Fresenius Kabi US
LLC for more information.

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12 Glossary of terms

Term Description
A Amperes
AC Alternating Current
°C Degrees Celsius
Cali. Calibration
CISPR Special International Committee on Radio Interference
DC Direct Current
d/min Drops/min
d/mL Drops/mL
EEC European Economic Community
EEPROM Electrically Erasable Programmable Read-Only Memory
ERR Error
°F Degrees Fahrenheit
g Grams
h Hours
H High
hPa Hectopascal
Hz Hertz
IEC International Electrotechnical Commission
IFU Instructions for Use
IT Information Technology
IV Intravenous
kg Kilograms
kHz Kilohertz
kPa Kilopascals
KVO Keep Vein Open
L Low
lbs Pounds
LOW BAT. Battery Low or Battery Empty
mA Milliamperes
mAh Milliampere-hours
mm Millimeter
mcl Microliters
mL Milliliters
mL/h Milliliters per hour
ms Milliseconds
mV Millivolts
M Middle

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 N No
OCCL. Occlusion
OCCL. LIMIT Occlusion alarm pressure level
PC Personal Computer
s Seconds
TAR.VOL. Target Volume (VTBI)
V Volts
VA Volt Amperes
VAC Volts alternating current
VDC Volts direct current
VOL. Alarm Sound Volume
VOL. INFUSED Volume infused
VTBI Volume To Be Infused
W Watt
Y Yes
μL Microliter

Fresenius Kabi JYM INfusia VP7

Distributed by:

Fresenius Kabi Jianyuan (Changsha) Medical Fresenius Kabi US LLC

Technology Co., Ltd.

Address: Address:
Building A2, No. 27, Wenxuan Road, National 3 Corporate Drive
Hi-Tech Industrial Development Zone, Changsha Lake Zurich, IL 60047,USA
410205, China www.fresenius-kabi.com

Tel: (86)(0)731-88801378 Post Market Quality Assurance:

855-354-6387

Customer Support Number: 800-333-6925

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