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.