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- Contents
- Table of Contents
- Troubleshooting
- Bookmarks
Table of Contents
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Table of Contents
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About the Device
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Features
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Symbols
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Device Description
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Installation Procedure
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Preparing an Infusion
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Loading Primary Administration Set
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Continuous Mode Infusion
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Time/Vtbi Programming
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Infusion Complete
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10 STEP Mode Infusion
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TPN Mode Infusion
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Intermittent Mode
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Blood Mode
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Prime IV Set Using PRIME Key
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Powering off
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Changing the Primary Solution Container
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Protocol Mode Infusion
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Save Infusion Parameters as a Protocol
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Alarms and Troubleshooting
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Definition
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Alarms
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Warnings
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Errors
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Maintenance
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Specifications
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Configurable Settings
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Storage
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Battery Care and Maintenance
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Cleaning
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Inspection Requirements
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Service Information
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Warranty
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Appendix
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Alarm Testing Procedure
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Approved Administration Sets
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Z-800 Infusion Pump
INSTRUCTIONS FOR USE
Revised 08/2010
Zyno Medical LLC
9 Tech Circle
Natick, MA, 01760
1-508-650-2008
Fax: 1-508-650-2006
www.zynomedical.com
Web:
Z-800 Instructions for Use.
1/69
P/N 800-600-01-08 Rev 08/10
Table ofContents
Advertisem*nt
Table of Contents
Summary of Contents for Zyno Medical Z-800
- Page 1 Z-800 Infusion Pump INSTRUCTIONS FOR USE Revised 08/2010 Zyno Medical LLC 9 Tech Circle Natick, MA, 01760 1-508-650-2008 Fax: 1-508-650-2006 www.zynomedical.com Web: Z-800 Instructions for Use. 1/69 P/N 800-600-01-08 Rev 08/10...
- Page 2 WARNING: Only use Zyno Medical provided IV sets with the Z-800 pump. There are risks associated with using any IV sets other than Zyno Medical 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.
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Page 3: Table Of Contents
Storage ..........................55 Battery Care and Maintenance ..…................... 56 Cleaning ……........................59 Inspection Requirements....................60 Service Information ......................61 Warranty..........................62 APPENDIX Alarm Testing Procedure ....................63 Approved Administration Sets ..................67 Z-800 Instructions for Use. 3/69 P/N 800-600-01-08 Rev 08/10... -
Page 4: About The Device
The Z-800 infusion pump must only be operated utilizing Zyno Medical’s proprietary administration sets. The sets are designed for use with the Z-800 pump as well as for gravity- flow stand-alone use. For specific administration set instructions, refer to the Directions For Use provided with the set. -
Page 5: Features
INTRODUCTION FEATURES The Z-800 flow rate range is from 1 to 999 ml/h. Flow Rates Free Flow Protection Z-800 Pump has a built in free flow clamp to prevent inadvertent free flow when the set is loaded in the pump. -
Page 6: Symbols
Ground Pole. Potential Equalization Conductor (PEC). Note: If the integrity of the PEC or Hospital Earth System is in question, operate the instrument using internal battery power. Z-800 Instructions for Use. 6/69 P/N 800-600-01-08 Rev 08/10... -
WARNING: Only use Zyno Medical provided IV sets in the Z-800 pump. WARNING: The Z-800 pump operation is strictly limited to trained operators whose competency in safe Z-800 pump operation and safe IV therapy practices has been tested and proven.
- Page 8 WARNING: Do not operate this device in the presence of flammable anesthetics mixture with air or oxygen or nitrous oxide. WARNING: Do not expose Z-800 pump to X-Rays, gamma rays or other radiation, or to strong electric or magnetic fields.
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Page 9: Device Description
DEVICE DESCRIPTION Pump Front View – Door Closed Z-800 Instructions for Use. 9/69 P/N 800-600-01-08 Rev 08/10... - Page 10 GETTING STARTED DEVICE DESCRIPTION (Continued) Pump Front View - Door Open Z-800 Instructions for Use. 10/69 P/N 800-600-01-08 Rev 08/10...
- Page 11 GETTING STARTED DEVICE DESCRIPTION (Continued) Pump Back View Z-800 Instructions for Use. 11/69 P/N 800-600-01-08 Rev 08/10...
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Page 12: Installation Procedure
3. Check to ensure pump door operates freely. 4. Check for any loose parts. NOTE: If any of the following conditions are observed, the Z-800 pump must be removed from use and inspected by qualified personnel: Look for any signs of physical damage from shipping. -
Page 13: Preparing An Infusion
GETTING STARTED PREPARING AN INFUSION Powering On the System 1. Connect the Z-800 Pump power cord to an AC power source. 2. Press and hold the ON/OFF key on the Z-800 Pump for 2 seconds. 3. System self-test begins: The diagnostics test causes all LED display segments and Status indicator lights to illuminate briefly. -
Page 14: Loading Primary Administration Set
Administration Sets section for a list of compatible sets). Open the administration set package, remove the set and close the roller clamp. WARNING: Some Z-800 IV sets configurations do NOT have set based free-flow protection feature. Steps 6 & 7 Make sure to close roller clamp before removing administration set from Z-800 pump. - Page 15 LOADING PRIMARY ADMINISTRATION SET (Continued) LOADING IV SET INTO Z-800 PUMP WARNING: Some Z-800 IV sets configurations do NOT have set based free- flow protection feature. Make sure to close roller clamp before removing administration set from Z-800 pump. Z-800 Instructions for Use.
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Page 16: Continuous Mode Infusion
10’s digit of Pri RATE to 20. 4. Press the single digit’s Up data entry key five times to increase the single digit of Pri RATE to 5. Z-800 Instructions for Use. 16/69 P/N 800-600-01-08 Rev 08/10... - Page 17 Titrate Flow Rate or VTBI During a Primary Infusion From the PAUSE screen, press PROG soft key; the pump will display primary infusion programming screen. User is then able to modify the primary RATE and primary VTBI parameters. Z-800 Instructions for Use. 17/69 P/N 800-600-01-08 Rev 08/10...
- Page 18 QUIT soft key to abort the action. NOTE: The VINF field will record cumulative infusion volume infused unless cleared by pressing the CLR soft key or turning the pump off/on and starting a new infusion. Z-800 Instructions for Use. 18/69 P/N 800-600-01-08 Rev 08/10...
- Page 19 7. Ensure no air bubbles are present in the line. 8. Hang the secondary fluid container at least 8 inches above the primary solution container. WARNING: Some Z-800 IV sets configurations do NOT have set based free-flow protection. Make sure to close roller clamp before removing administration set from Z-800 pump.
- Page 20 3. Soft Keys: Allow user to access pump configuration and primary infusion programming screen. CONFIG: Access pump configuration. PRI: Access primary infusion programming. Up/Down Arrows: Select parameter items. Z-800 Instructions for Use. 20/69 P/N 800-600-01-08 Rev 08/10...
- Page 21 2. Press the 100’s Up data entry key once to increase the 100 digit of Sec VTBI to 100. 3. Press 10’s Up data entry key five times to increase the 10 digit of Sec VTBI to 50. Z-800 Instructions for Use. 21/69 P/N 800-600-01-08 Rev 08/10...
- Page 22 2 short beeps. The Main Display will switch-over to PRI RATE, PRI VTBI and PRI VINF. WARNING: Do not over-program VTBI. Program the actual amount of the fluid in the IV bag. Z-800 Instructions for Use. 22/69 P/N 800-600-01-08 Rev 08/10...
- Page 23 From PAUSE state, press RUN/STOP key to resume infusion. Changing Rate or VTBI During a Secondary Infusion From the PAUSE screen, press PROG soft key; the Z-800 pump will enter secondary infusion programming screen. User is able to modify the secondary RATE and secondary VTBI parameters.
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Page 24: Time/Vtbi Programming
GETTING STARTED TIME/VTBI Programming Access TIME/VTBI Programming Option The Z-800 pump provides TIME/VOLUME programming options for Continuous Mode Infusion. The user may choose the infusion programming parameter option in the pump configuration screen. 1. Press the CONFIG soft-key to access pump... - Page 25 TIME/VTBI infusion parameters may be programmed by using the UP/DOWN Arrow keys and Data Entry keys. WARNING: Do not over-program VTBI. Program the actual amount of the fluid in the IV bag. Z-800 Instructions for Use. 25/69 P/N 800-600-01-08 Rev 08/10...
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Page 26: Infusion Complete
Press RUN/STOP key to acknowledge the infusion complete message. The pump will be paused and the KVO infusion will be stopped. WARNING: Some Z-800 IV sets configurations do NOT have set based free-flow protection. Make sure to close roller clamp before removing administration set from Z-800 pump. -
Page 27: 10 Step Mode Infusion
1. Turn on the pump and select NEW INFUSION. 2. Use Up/Down Arrow keys to highlight 10 STEP MODE and press the Select soft-key. 3. The pump will display the Programming screen of the 10 STEP mode infusion. Z-800 Instructions for Use. 27/69 P/N 800-600-01-08 Rev 08/10... - Page 28 RUN/STOP to begin the infusion locks in the list. To edit the list after an infusion is underway, press RUN/STOP to pause, and then press the PROG soft key to edit the list. Z-800 Instructions for Use. 28/69 P/N 800-600-01-08 Rev 08/10...
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Page 29: Tpn Mode Infusion
4. Turn on the pump and select NEW INFUSION. 5. Use Up/Down Arrow keys to highlight 4. TPN MODE and press the Select soft-key. 6. The pump will display the Programming screen of the TPN infusion. Z-800 Instructions for Use. 29/69 P/N 800-600-01-08 Rev 08/10... - Page 30 The TPN Ramp Time parameters may be programmed by using the UP/DOWN Arrow keys and Data Entry keys. WARNING: Do not over-program VTBI. Program the actual amount of the fluid in the IV bag. Z-800 Instructions for Use. 30/69 P/N 800-600-01-08 Rev 08/10...
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Page 31: Intermittent Mode
In the intermittent mode, pump runs for the period programmed, then idles before next period run. The sum of the ―run‖ and the ―idle‖ time is the cycle time, as illustrated below. Z-800 Instructions for Use. 31/69 P/N 800-600-01-08 Rev 08/10... - Page 32 UP/DOWN Arrow keys and Data Entry keys. Note: During idle period, pump runs at KVO rate. Volume infused during idle period is counted. Pump alarms ―Infusion Completed‖ once VINF (volume infused) equals programmed Total VTBI. Z-800 Instructions for Use. 32/69 P/N 800-600-01-08 Rev 08/10...
- Page 33 6 hours (Cycle Time). The run time for each period is 10 minutes (Period Time), idle time in each cycle is 5 hours 50 minutes. The parameters can be programmed as follows: Total VTBI: 200mL Cycle Time: 06:00 Period VTBI: 50mL Period Time: 10 minutes Z-800 Instructions for Use. 33/69 P/N 800-600-01-08 Rev 08/10...
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Page 34: Blood Mode
Use Up/Down Arrow keys to highlight 6. BLOOD INFUSION and press the Select soft- key. The pump will confirm that current application is ―BLOOD INFUSION‖ and display the Programming screen of the BLOOD INFUSION mode. Z-800 Instructions for Use. 34/69 P/N 800-600-01-08 Rev 08/10... - Page 35 CONFIG: Access pump configuration. Up/Down Arrows: Highlight the selected parameter item. The RATE and VTBI parameters may be programmed by using the UP/DOWN Arrow keys and Data Entry keys. Z-800 Instructions for Use. 35/69 P/N 800-600-01-08 Rev 08/10...
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Page 36: Prime Iv Set Using Prime Key
The maximum prime volume is 10mL. Upon reaching the maximum prime volume, the prime will stop. WARNING: Patient must be disconnected before utilizing the PRIME key. Z-800 Instructions for Use. 36/69 P/N 800-600-01-08 Rev 08/10... - Page 37 ―PANEL UNLOCKED‖ message will be displayed for 3 seconds. Keypad Unlock is done at Infusion Programming screen. User CANNOT lock/unlock keypad while pump is running an infusion. Z-800 Instructions for Use. 37/69 P/N 800-600-01-08 Rev 08/10...
- Page 38 3. Upon user confirmation, the current VINF parameter will be reset to 0 ml. NOTE: The VINF field will record cumulative infusion volume infused unless cleared by pressing the CLR soft key. Z-800 Instructions for Use. 38/69 P/N 800-600-01-08 Rev 08/10...
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Page 39: Powering Off
GETTING STARTED POWERING OFF Stop the Z-800 pump by pressing the RUN/STOP key during an infusion. Press and hold down the ON/OFF key for 2 seconds. The pump will be put on standby state. NOTE: Pump cannot be powered off during an infusion. -
Page 40: Changing The Primary Solution Container
GETTING STARTED CHANGING PRIMARY SOLUTION CONTAINER 1. Stop the Z-800 pump by pressing the RUN/STOP key during an infusion. 2. Close roller clamp. 3. Remove empty solution container. 4. Spike new container. 5. Enter primary infusion programming screen. Highlight Pri VTBI parameter. Use data entry keys to enter desired VTBI. -
GETTING STARTED CHANGING AND RELOADING IV SET DURING INFUSION Stop the Z-800 pump by pressing the RUN/STOP key during an infusion. Close roller clamp. Disconnect administration set from the patient. Open pump door. Remove administration set from the pump. Prime and load a new administration set, as described in Prepare Infusion section.
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Page 42: Protocol Mode Infusion
RUN/STOP key Verify displayed infusion parameter entries (Primary Rate, Primary VTBI, Secondary Rate, and Secondary VTBI). If a clamp is engaged, remove the clamp. Press RUN/STOP key to start the infusion. Z-800 Instructions for Use. 42/69 P/N 800-600-01-08 Rev 08/10... -
Page 43: Save Infusion Parameters As A Protocol
0 through 9 and SPACE. Use Up/Down Arrow to move curser back and forth. 5. Press SAVE soft key to associate the current programmed infusion parameters with the protocol name as entered. Z-800 Instructions for Use. 43/69 P/N 800-600-01-08 Rev 08/10... -
Page 44: Alarms And Troubleshooting
ALARMS AND TROUBLESHOOTING To enhance safety and ease of operation, the Z-800 Pump provides a full range of audio and visual alarms, warnings, and prompts. DEFINITIONS Error An audio and visual signal that a failure has been detected. Immediate action is required. -
Page 45: Alarms
2. Acknowledge the alarm by pressing too low for pump RUN/STOP key. operation. 3. The infusion is paused. 4. Press RUN/STOP key again to resume infusion. Z-800 Instructions for Use. 45/69 P/N 800-600-01-08 Rev 08/10... -
Page 46: Warnings
ALARMS AND TROUBLESHOOTING WARNINGS Warning Meaning Response Low Battery Z-800 pump is operating on Plug the power cord into an battery power and low battery AC power outlet. Audio condition is detected. Battery warning will be silenced when has 30 minutes or less of power AC power is detected. -
Page 47: Errors
Press RUN/STOP key to silence alarm an error on the pump. and to stop using the affected pump. Infusion stops. The pump must be taken out of service until serviced by qualified service personnel. Z-800 Instructions for Use. 47/69 P/N 800-600-01-08 Rev 08/10... -
Page 48: Maintenance
Automatic when pump plugged into an AC power source Pump Housing: Cast Aluminum & Sheet Metal Weight: 2.6 kilograms, 5.7 lbs 8.6‖H x 5.7‖W x 5.3‖D Dimensions: Manufactured in accordance to ISO 9001:2000 and ISO Standards: 13485:2003. Z-800 Instructions for Use. 48/69 P/N 800-600-01-08 Rev 08/10... - Page 49 Temperature: +10°C to +40 °C (+59 °F to + 113 °F) Humidity: 30 % to 75% R.H. at +40 °C, non-condensing Air pressure: 700hPa to 1060hPa IV Administration Set: Use only Zyno Medical approved IV sets. Alarms: Air-in-Line; Occlusion; Door Open;...
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Page 50: Configurable Settings
PRESSURE sub menu. Press QUIT soft key again to exit the BIOMED OPTION menu WARNING: The factory default settings should be used unless qualified clinical personnel determine that other customized settings are appropriate and safe. Z-800 Instructions for Use. 50/69 P/N 800-600-01-08 Rev 08/10... - Page 51 MAINTENANCE CONFIGURABLE SETTINGS (Continued) Adjusting the Air-In-Line Alarm Threshold The Z-800’s Air-In-Line sensor detects an air bubble in the administration set tubing. Air-In-Line alarm threshold can be adjusted in the BIOMED OPTION configuration menu. Alarm threshold can be adjusted to air bubble size from a volume of 2 micro-liters to 280 micro-liters.
- Page 52 CONFIGURABLE SETTINGS (Continued) Enable/Disable Drip Sensor Option The Z-800 pump has an optional external drip sensor, which may be used to detect a fluid container empty event. The user may enable or disable the drip sensor in the BIOMED OPTION configuration menu. When...
- Page 53 MAINTENANCE CONFIGURABLE SETTINGS (Continued) Adjusting the Alarm Volume The Z-800 pump is able to generate multiple audio alert tunes to indicate pump alarm, warning, error or prompt. Audio alarm volume may be adjusted by the user. 1. From the configuration menu, Select 9.
- Page 54 MAINTENANCE CONFIGURABLE SETTINGS (Continued) Adjusting the LCD Brightness The Z-800 Main LCD Display’s brightness level can be adjusted by the user. 1. From the configuration menu, Select 9. FACTORY SET. 2. In the FACTORY SETTING menu, Select 9.1. BRIGHTNESS. 3. In the BRIGHTNESS sub-menu, use Up/Down...
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Page 55: Storage
Store the pump away from excessive heat, cold, or humidity. Keep the pump plugged into an AC outlet during storage, to ensure a fully charged battery when needed. (AC indicator light) will be on whenever the Z-800 Pump is plugged in. Z-800 Instructions for Use. -
Page 56: Battery Care And Maintenance
When the pump runs on battery power, the POWER indicator is off, and BATTERY indicator is on. The Z-800 Pump is equipped with a standard configuration of 9.6 volt 1800mAh Nickel-Metal-Hydride battery, or a extended battery option of 9.6 volt 4500mAh Nickel-Metal- Hydride battery. - Page 57 This will be observed by user as low apparent run times and premature low battery warning and alarms. The lowered capacity is not permanent, but may require 2-3 full discharge/charge cycles to recover. Z-800 Instructions for Use. 57/69 P/N 800-600-01-08 Rev 08/10...
- Page 58 The battery capacity should be checked at least once every 12 months. CAUTION: Battery replacement should be If the Z-800 pump is to be stored at temperatures in excess performed by qualified of 86 °F (30 °C) for one or more months, the battery should service personnel while the be removed and placed in an environment between 50 –...
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Page 59: Cleaning
2. Use soft cloth dampened with warm water and a mild nonabrasive cleaning solution to clean all exposed surfaces. Do not spray any fluids directly on the instrument. For sanitizing or antibacterial treatment, use 10% bleach solution and water. Z-800 Instructions for Use. 59/69 P/N 800-600-01-08 Rev 08/10... -
Page 60: Inspection Requirements
PERIODIC MAINTENANCE: Periodic maintenance of the hardware is required at least once per year. A service agreement may be obtained from Zyno Medical for the performance of all required periodic maintenance. NOTE: Periodic maintenance should only be performed by qualified service personnel. -
Page 61: Service Information
MAINTENANCE SERVICE INFORMATION If a Z-800 Pump fails to respond as described in this Instruction for Use and the cause cannot be determined, do not use the affected instrument. Contact qualified service personnel. Within the United States, application and service information may be obtained by writing to Zyno Medical LLC. -
Page 62: Warranty
Zyno Medical LLC. (hereinafter referred to as ―Zyno Medical‖) warrants that: A. Each new Zyno Medical Z-800 infusion pump is free from defects in material and workmanship under normal use and service for a period of one (1) year from the date of delivery by Zyno Medical to the original purchaser. -
Page 63: Appendix
―AIR-IN-LINE‖. The infusion will be stopped. 5. Press the RUN/STOP key again to acknowledge the alarm condition. Z-800 Pump will be in PAUSE state. ―PAUSE‖ message will appear on the display screen. 6. Clear the Air-in-Line condition. Press RUN/STOP key again to resume infusion. - Page 64 Main Display will show alarm screen with ―Occlusion‖. The infusion will be stopped. 5. Press RUN/STOP key to acknowledge the alarm condition. Z-800 Pump will be in PAUSE state. ―PAUSE‖ message will appear on the display screen. 6. Open the roller clamp to release pressure. Press RUN/STOP key again to resume infusion.
- Page 65 APPENDIX ALARM TESTING PROCEDURE (Continued) Battery Test 1. Connect the Z-800 pump to an approved AC power outlet for at least 18 hours to allow the battery to fully charge. 2. Unplug the power cord from the AC power. Turn on the device.
- Page 66 Time interval between the Battery Empty Alarm and the pump shut down is less than 2 minutes. Pump configuration setting changed after battery depletion. Any of the current infusion parameters is not preserved. Z-800 Instructions for Use. 66/69 P/N 800-600-01-08 Rev 08/10...
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Page 67: Approved Administration Sets
WARNING: Use only administration sets labeled as Zyno Medical with the Z-800 Infusion Pump System. The use of any other set for use with Z-800 system may cause improper instrument operation, resulting in inaccurate fluid delivery or other potential hazards. - Page 68 Needle-less Access Port; back check valve; universal spike drip chamber (20 drops/ml); roller clamp, male luer lock; non-DEHP tubing; Latex-free; 0.22 micron IV Express® filter; Anti-Free-Flow Valve; Approximate priming volume 16 ml Z-800 Instructions for Use. 68/69 P/N 800-600-01-08 Rev 08/10...
- Page 69 2 spikes; drip chamber with 180 micron blood filter; roller clamp, male luer lock; non-DEHP tubing; Latex-free; Approximate priming volume 30 Zyno Medical LLC. 9 Tech Circle Natick, MA, 01760 Phone: 1-508-650-2008 Fax: 1-508-650-2006 Z-800 Instructions for Use. 69/69 P/N 800-600-01-08 Rev 08/10...
