Zyno Medical Z-800F User manual

Z-800F Instructions for Use. 1
P/N 800F-IFU-2602, Rev. O
Z-800F Infusion Pump
INSTRUCTIONS FOR USE
Zyno Medical LLC
177 Pine Street
Natick, MA 01760
1-508-650-2008
Fax: [phone]
Web: www.zynomed.com

2 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
WARNING:
Only use Zyno Medical provided IV sets with the Z-800F Infusion Pump. There are risks
associated with using any IV Sets other than Zyno Medical IV Sets with this device.
Zyno’s warranty for its device will be null and void and Zyno will assume no responsibility
for any incidents that may occur if the device is not utilized strictly in accordance with its
product labeling.
SAFETY STANDARD
The Z-800F Infusion Pump meets all applicable safety standards for volumetric infusion
pump devices, corresponding to IEC 60601-1 and IEC 60601-2-24.
Copyright © 2017 Zyno Medical, LLC
Part number 800F-IFU-2602

Z-800F Instructions for Use. 3
P/N 800F-IFU-2602, Rev. O
TableofContents
INTRODUCTION ................................................................................................................. 5
ABOUT THE DEVICE..................................................................................................... 5
FEATURES ....................................................................................................................... 6
SYMBOLS......................................................................................................................... 7
GETTING STARTED........................................................................................................... 8
WARNINGS & CAUTIONS............................................................................................. 8
DEVICE DESCRIPTION................................................................................................ 11
INSTALLATION PROCEDURE.................................................................................... 14
PREPARING AN INFUSION......................................................................................... 15
LOADING PRIMARY ADMINISTRATION SET ........................................................ 16
INFUSION MODE INFORMATION................................................................................. 18
CONTINUOUS MODE................................................................................................... 18
TIME/VTBI PROGRAMMING...................................................................................... 26
INFUSION COMPLETE................................................................................................. 28
TPN MODE INFUSION.................................................................................................. 29
10-STEP MODE INFUSION .......................................................................................... 31
INTERMITTENT MODE INFUSION............................................................................ 34
BLOOD INFUSION........................................................................................................ 37
MANAGING INFUSION.................................................................................................... 39
PRIME THE ADMINISTRATION SET USING PRIME KEY..................................... 39
KEYPAD LOCKOUT..................................................................................................... 40
CLEAR VOLUME INFUSED ........................................................................................ 41
POWERING OFF............................................................................................................ 42
CHANGING PRIMARY SOLUTION CONTAINER.................................................... 43
CHANGING AND RELOADING IV SET DURING INFUSION................................. 44
PROTOCOL MODE INFUSION.................................................................................... 45
SAVE INFUSION PARAMETERS AS PROTOCOL.................................................... 46
ALARMS AND TROUBLESHOOTING ........................................................................... 47
DEFINITIONS................................................................................................................. 47
ALARMS......................................................................................................................... 48
WARNINGS.................................................................................................................... 50
ERRORS.......................................................................................................................... 52
MAINTENANCE................................................................................................................ 53

4 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
SPECIFICATIONS.......................................................................................................... 53
CONFIGURABLE SETTINGS....................................................................................... 55
STORAGE AND TRANSPORTATION......................................................................... 71
BATTERY CARE AND MAINTENANCE ................................................................... 72
CLEANING..................................................................................................................... 75
INSPECTION REQUIREMENTS .................................................................................. 76
SERVICE INFORMATION............................................................................................ 78
WARRANTY .................................................................................................................. 79
APPENDIX.......................................................................................................................... 80
ALARM TESTING PROCEDURE................................................................................. 80
APPROVED ADMINISTRATION SETS ...................................................................... 84
ACCESSORIES LIST ..................................................................................................... 86

INTRODUCTION
Z-800F Instructions for Use. 5
P/N 800F-IFU-2602, Rev. O
INTRODUCTION
ABOUT THE DEVICE
The Z-800F Infusion Pump is intended to provide accurate
delivery of parenteral fluids, blood and blood products to a
human patient when administered by a qualified health care
professional.
User Qualification
The Z-800F Infusion Pump is intended for use at the
direction or under the supervision of licensed physicians or
certified healthcare professionals who are trained in the use
of the Z-800F Infusion Pump and the administration of
parenteral fluids and drugs, blood and blood products. This
training should emphasize patient safety and prevention of
error.
This document provides directions for use of the Z-800F
Infusion Pump. To ensure safe usage, please read the entire
instruction manual before using the device.
The Z-800F Infusion Pump must only be operated utilizing
Zyno Medical’s proprietary administration sets. The sets are
designed for use with the Z-800F Infusion Pump as well as
for gravity-flow stand-alone use. For specific IV
Administration Set instructions, refer to the Directions For
Use provided with the set. For priming and loading
instructions, refer to “Loading Primary Administration Set”
and “Loading Secondary Administration Set” sections of this
document.
Contraindication: None known.

INTRODUCTION
6 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
FEATURES
Flow Rates
The Z-800F Infusion Pump flow rate range is from 1 to 1200 ml/h.
Free Flow Protection
The Z-800F Infusion Pump has a built in free flow clamp
to prevent inadvertent free flow when the set is loaded in
the pump.
The Z-800F Infusion Pump also has an IV Set based anti-
free-flow module to prevent inadvertent free flow when
the set is unloaded from the pump.
WARNING: Make sure to only use 800F IV Sets
with IV Set based anti-free flow clamp, and make sure to
close the roller clamp before removing administration set
from Z-800F Infusion Pump.
Occlusion Pressure The Z-800F Infusion Pump provides 14 levels of
adjustable downstream occlusion alarm thresholds
between 4 psi and 30 psi.
Secondary Infusions Secondary infusions may be delivered at a specified
secondary delivery rate and secondary volume-to-be-
infused (VTBI) independent of the primary infusion
parameters. When secondary VTBI is greater than zero,
the pump will always execute secondary infusion first.
Automatic changeover occurs to the primary infusion
parameters when the secondary infusion is complete. A
Zyno Medical proprietary primary administration set
with a back check valve must be used.
System Configuration The system configuration mode allows qualified
personnel to customize device settings.
Tamper Resist The Tamper Resist feature provides a quick, one touch
lockout of the front keypad.
Volume-To-Be-Infused
(VTBI) The volume-to-be-infused (VTBI) range is from 1 to
9999 ml in 1 ml increments.

INTRODUCTION
Z-800F Instructions for Use. 7
P/N 800F-IFU-2602, Rev. O
SYMBOLS
Electrical Shock Protection Rating: Type BF.
IPX1 Protection against fluid ingress: Drip Proof.
Attention: Refer to accompanying documentation.
Rx Only Federal (U.S.A) law restricts this device to sale by or on the
order of a physician.
Fuse: 2X2TA.

GETTING STARTED
8 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
GETTING STARTED
WARNINGS & CAUTIONS
The following Warnings and Cautions should be strictly followed to avoid harm to patients
and pump operators:
WARNING: Zyno Medical assumes no responsibility for incidents that may occur
if its product is not used in accordance with its product labeling.
WARNING: Only use Zyno Medical provided IV Sets with the Z-800F Infusion
Pump.
WARNING: The Z-800F Infusion Pump operation is strictly limited to trained
operators whose competency in safe Z-800F Infusion Pump operation and safe IV
therapy practices has been tested and proven.
WARNING: Make sure the pump is stable by fastening securely to an IV Pole, or
resting on a flat surface. IV Poles vary in quality and stability. Avoid fastening the
pump too high on the pole, and test for stability before using.
WARNING: Prior to use, always verify the proper function of the display, audible
and visual alarms.
WARNING: Verify there are no kinks in the tubing when loading into the pump.
WARNING: Always read and follow the instructions that accompany the fluid
container and IV administration sets used. Carefully follow the instructions in this
document for loading, removing, and reloading the IV Set. Adjust the pumping
section of the IV Set every 24 hours, and replace the IV Set within 72 hours.
WARNING: To prevent free flow, make sure to load the IV Set in the Infusion
Pump before connecting the IV set to a patient.
WARNING: To prevent free flow, make sure to disconnect the IV Set from the
patient before unloading the IV set from the Z-800F Infusion Pump.
WARNING: Disconnect the IV Set from the patient before purging air bubbles out
of IV Tubing.
WARNING: Make sure to close the roller clamp before removing IV administration
set from the Z-800F Infusion Pump.
WARNING: Do not over-program the VTBI. Program the actual amount of the
fluid in the IV bag.
WARNING: After starting an infusion, make sure drops are falling in the Drip
Chamber. If no drops are falling, make sure the Roller Clamp is open. If the Roller
Clamp is open and still no drops are falling, replace and dispose of the IV
Administration Set.

GETTING STARTED
Z-800F Instructions for Use. 9
P/N 800F-IFU-2602, Rev. O
WARNINGS & CAUTIONS (Continued)
WARNING: The Air In-Line Sensor cannot recognize the introduction of air at 3-
way Stopcocks, Infusion Ports, and other Lines/Tubes below the Infusion Pump.
WARNING: Do not operate this device in the presence of Flammable Anesthetics
mixture with Air, Oxygen or Nitrous Oxide.
WARNING: Do not expose the Z-800F Infusion Pump to X-Rays, Gamma Rays or
other Radiation, or to strong Electric or Magnetic Fields.
WARNING: The factory default settings should be used unless qualified clinical
personnel determine that other customized settings are appropriate and safe.
WARNING: The manufacturer cannot assure the accuracy and/or safety of the
Infusion Pump if it is not regularly maintained as recommended in the Z-800F
Infusion Pump Instructions For Use Manual.
WARNING: Flow rate accuracy can be affected by one or a combination of the
following factors: fluid viscosity; fluid temperature; head height; back pressure;
incompatible IV sets or compatible set with unusually small or large diameters or
unusually stiff materials.
CAUTION: Please read the entire contents of this manual before using the Z-800F
Infusion Pump.
CAUTION: USA Federal and Canadian laws restrict this device to sale by or on the
order of a physician.
CAUTION: There are no user serviceable parts inside. Refer all service, repair, and
calibration to qualified technical personnel. Do not make unauthorized
modifications.
CAUTION: To avoid mechanical or electronic damage, do not steam, autoclave or
immerse the pump in any fluids or cleaning solutions, and do not spray such fluids
directly on the pump. Always disconnect electrical power cord from outlet before
cleaning to prevent electrical shock. The IPX1 rating means that the pump is
protected against vertical dripping water.
CAUTION: Do not attempt to infuse two fluids simultaneously using the Z-800F
Infusion Pump.
CAUTION: Operating the Z-800F Infusion Pump near equipment that radiates
high-energy radio frequencies (electrosurgical/cauterizing equipment, portable
radios, cellular telephones, etc.), or under direct sunlight towards top of the infusion
pump, may cause false alarm conditions. If this happens, reposition the device away
from the source of interference or use an appropriate clinical alternative.

GETTING STARTED
10 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
WARNINGS & CAUTIONS (Continued)
CAUTION: Always verify displayed infusion parameters (Primary Rate, Primary
VTBI, Secondary Rate, Secondary VTBI) with the prescription before starting
infusion.
CAUTION: Grounding reliability can only be achieved when equipment is
connected to an equivalent receptacle marked "hospital only" or Hospital grade.

GETTING STARTED
Z-800F Instructions for Use. 11
P/N 800F-IFU-2602, Rev. O
DEVICE DESCRIPTION
Pump Front View – Door Closed

GETTING STARTED
12 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
DEVICE DESCRIPTION (Continued)
Pump Front View - Door Open

GETTING STARTED
Z-800F Instructions for Use. 13
P/N 800F-IFU-2602, Rev. O
DEVICE DESCRIPTION (Continued)
Pump Back View

GETTING STARTED
14 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
INSTALLATION PROCEDURE
UNPACK THE PUMP
The Z-800F Infusion Pump is supplied complete with
A standard detachable, listed/certified IEC Hospital
Grade electrical cord
Pole Clamp pre-mounted at 45 degree angle to the
pump
Instruction for Use
1. Remove the pump module from its carton.
2. Inspect the pump.
3. Check to ensure the pump door operates freely.
4. Check for any loose parts.
NOTE: If any of the following conditions are observed,
the Z-800F Infusion Pump must be removed from use and
inspected by qualified personnel:
Look for any signs of physical damage from
shipping.
LED segments are not illuminated during system
power-on self-test.
Indicator lights do not illuminate.
Audio tone does not sound.
Main Display does not appear backlit, appears
irregular, or has evidence of a row of pixels not
functioning properly.
MOUNT PUMP TO IV POLE
Attach the pump to an IV Pole by turning the knob on the
pole clamp clockwise, or place the pump on a flat, stable
surface.

GETTING STARTED
Z-800F Instructions for Use. 15
P/N 800F-IFU-2602, Rev. O
PREPARING AN INFUSION
Powering On the System
1. Connect the Z-800F Infusion Pump Power Cord to an
AC power source.
2. Press and hold the ON/OFF key on the Z-800F Infusion
Pump for 2 seconds.
3. System self-test begins:
The diagnostics test causes all LED display
segments and Status indicator lights to illuminate
briefly.
The Power Indicator illuminates.
An Audio tone sounds.
4. The Main Display shows the Zyno Medical Logo, Pump
Serial Number, Software Version and pump safety
configurations during the system power-on self-test.
5. Upon completion of system power-on self-test, a New
Infusion prompt screen will be displayed prompting the
user to choose either resume a previously interrupted
infusion or start with a new infusion.
6. If the user elects to resume the previously interrupted
infusion, the pump will enter into the Programming
screen of the previous selected infusion mode and with
the previous infusion parameters populated.
7. If the user elects to start a new infusion, the pump will
prompt user to main screen (see right image). For
manual programming, the user should select
PROGRAM. After selection, the pump will prompt user
to select infusion mode. Upon selection, the pump will
enter into the Infusion Programming screen of the
selected Infusion Mode with all infusion parameters
reset to zero. The user may choose one of the following
infusion modes:
Continuous Mode with Rate/VTBI parameters
Continuous Mode with Time/VTBI parameters
TPN Auto Ramp Mode
10 Step Mode Rate/VTBI
10 Step Mode Time/VTBI
Intermittent
Blood Infusion

GETTING STARTED
16 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
LOADING PRIMARY ADMINISTRATION SET
Preparing the Primary Solution Container
Prepare the primary solution container in accordance with the
manufacturer’s directions for use.
Preparing the Primary Administration Set
Use only Zyno IV Administration Sets (refer to Approved
Administration Sets section for a list of compatible sets).
Open the administration set package, remove the set and close
the roller clamp.
WARNING: Make sure to close Roller Clamp before
removing IV Administration Set from Z-800F Infusion
Pump.
Loading Primary Administration Set
1. Make sure the Anti-Free Flow Pinch Clamp is attached
on the primary set and it’s in open position. (see picture
“Step 1”)
2. Insert the Set Spike into prepared fluid container
following accepted clinical procedure, and hang the
container approximately 20 inches above the Infusion
Pump.
3. Fill the Drip Chamber to 1/3 full by squeezing it.
4. Open the Roller Clamp slowly to prime tubing. Invert
and tap the back Check Valve and any luer lock sites to
clear the air from the IV Administration Set.
5. Close the Roller Clamp and the Pinch Clamp.
6. Close the pump door. Turn on the pump. After the pump
has finished the power-on-self-test, open the pump door.
7. Using a thumb, firmly push the metal button of the Anti-
Free-Flow Module, slide the Clamp into the Clamp
Holder from the top (pay attention to the orientation of
the clamp) and release the button. (See picture “Step 7”)
8. Using a fingertip, firmly push the tubing into the gap of
the tubing guides on the Pumping Fingers. (See picture
“Step 8”)
9. Using a fingertip, firmly push the tubing into the gap of
the Air-in-Line Sensor. (See picture “Steps 9 & 10”)
10. Align the tubing on top of the gap of the Free Flow
Clamp. Do not force the tubing into the clamp. The
tubing will be loaded into the Free Flow Clamp
automatically when the pump door is closed.
11. Close the pump door by pushing down the pump door
handle. (See picture “Step 11”)
Step 1
Step 7
Step 8
Step 9 & 10
Step 11

GETTING STARTED
Z-800F Instructions for Use. 17
P/N 800F-IFU-2602, Rev. O
LOADING PRIMARY ADMINISTRATION SET (Cont.)
12. Open the IV set roller clamp and confirm that there is NO FLOW in the IV set drip
chamber. Connect the administration set to the patient’s injection site.
LOADING IV SET INTO Z-800F PUMP
WARNING: Make sure to close roller clamp before removing administration set
from Z-800F pump.

INFUSION MODE INFORMATION
18 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
INFUSION MODE INFORMATION
CONTINUOUS MODE
CONTINUOUS MODE-PRIMARY INFUSION
Primary Infusion Programming Screen
The user may choose to program the continuous infusion
either in RATE/VTBI or TIME/VTBI. The primary infusion
programming screen contains the following display areas:
1. Status Bar: The Status Bar displays current operating
mode, current pump state, and volume infused.
CONT: Indicates the current application mode is
Continuous Mode Operation
VINF: Indicates the Volume Infused during the
current infusion
2. Infusion Parameters: -- Primary Flow Rate and
Primary Volume to Be Infused
Pri RATE: Primary Flow Rate
Pri VTBI: Primary VTBI
3. Keys: Allows user to access pump configuration and
secondary infusion programming screen
CONFIG: Access configurable settings
SEC: Access the secondary infusion programming
Up/Down Arrows: Select parameter items
Home Key: Access Infusion Mode menu
WARNING: Do not over-program VTBI.
Program the actual amount of the fluid in the IV
bag.
Change Primary Flow Rate
Use Up/Down Arrow keys to highlight Pri RATE. Use the
Data Entry keys to modify the corresponding digits of Pri
RATE value.
Example: Programming Pri RATE = 125 mL/h
1. Use Up/Down Arrow keys to highlight Pri RATE.
2. Press the 100 Up data entry key once to increase the
100 digit of Pri RATE to 100.
3. Press the 10 Up data entry key twice to increase the
10 digit of Pri RATE to 20.
Press the single digit Up data entry key five times to
increase the single digit of Pri RATE to 5.

INFUSION MODE INFORMATION
Z-800F Instructions for Use. 19
P/N 800F-IFU-2602, Rev. O
CONTINUOUS MODE-PRIMARY INFUSION (Continued)
Change Primary VTBI
Use the Up/Down Arrow keys to highlight Pri VTBI. Use
the Data Entry keys to modify the corresponding digits of
Pri VTBI value.
Example: Programming Pri VTBI = 250 ml
Use the Up/Down Arrow keys to highlight Pri VTBI.
Press the 100 Up data entry key twice to increase the
100 digit of Pri VTBI to 200.
Press the 10 Up data entry key five times to increase
the 10 digit of Pri VTBI to 50.
Start Primary Infusion
Verify the displayed infusion parameter entries (Primary
Rate, Primary VTBI). If a clamp is engaged, remove the
clamp. Press RUN/STOP key to start the infusion.
Stopping and Resuming a Primary Infusion
Press the RUN/STOP key during infusion. The infusion will
be paused. The PAUSE screen will be displayed.
From the PAUSE state, press the RUN/STOP key to resume
infusion.
Titrate Flow Rate or VTBI During a Primary Infusion
From the PAUSE screen, press the PROG key; the pump
will display primary infusion programming screen. The user
is then able to modify the primary RATE and primary VTBI
p
arameters.

INFUSION MODE INFORMATION
20 Z-800F Instructions for Use
P/N 800F-IFU-2602, Rev. O
CONTINUOUS MODE-PRIMARY INFUSION (Continued)
Primary Infusion Execution
During an infusion, the two Infusion Status Indicator LEDs
will illuminate in green and toggle once per second.
The primary infusion execution display contains the
following contents:
Status Bar: The Status Bar displays the current operating
mode, current pump state, and volume infused.
PRI: Primary infusion
RUN: Pump RUN state
TL: Time Left in HH:MM format for the current
infusion
Infusion Parameters: Current infusion parameters.
RATE field displays primary flow rate.
VTBI field counts down to show remaining VTBI.
VINF field counts up to show volume infused.
3 minutes before infusion completes, a short audio prompt
tone will sound twice. Along with the audio prompt, the
screen will display “INFUSION NEAR END” message.
This alert will repeat every 5 seconds until the infusion is
complete.
At completion of the infusion, an audio prompt sounds and
the screen will display “INFUSION COMPLETE – KVO.”
This alert will repeat every 5 seconds until user
intervention. During KVO state, the Flow Rate Indicator
will change to display KVO flow rate.
Clearing the Volume Infused During a Primary Infusion:
Press the RUN/STOP key to PAUSE the primary infusion. Exit
the PAUSE screen by pressing the PROG key. From the
Primary SETUP screen, press and hold the CLR key. An
audio/visual prompt will be presented requesting user
confirmation to clear VINF. Press the YES key to confirm. The
VINF field will be reset to 0 ml. The user can press the NO key
to abort the action.
NOTE: The VINF field will record cumulative infusion
volume infused unless cleared by the user pressing the CLR
key or turning the pump off/on and starting a new infusion.