ZOLL 330 Operator'S Manual Download Page 78

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Specifications

A-6

www.zoll.com

906-0330-01-01 Rev. D

Basic Safety and Essential Performance

Instructions for maintaining basic safety and essential performance with regard to
electromagnetic disturbances for the expected service life:

•

Perform preventive maintenance on the device on an annual basis.

•

Follow service procedures as defined in the service manual to ensure EMC performance.

•

Be prepared to use a manual aspiration technique if the use location is near (e.g. less than
1.5 km from) AM, FM, or TV broadcast antennas.

Summary of Contents for 330

Page 1: ...ZOLL Model 330 Multifunction AspiratorOperator s Guide 906 0330 01 01 Rev D...

Page 2: ...the United States and or other countries All other trademarks are the property of their respective owners Limited Copyright Release Permission is hereby granted to any military governmental agency to...

Page 3: ...raphical User Interface GUI 1 4 Conventions 1 6 Abbreviations and Acronyms 1 6 ZOLL Model 330 Multifunction Aspirator Indications for Use 1 7 Aspirator 1 7 Features 1 7 Warnings 1 7 General 1 7 Aspira...

Page 4: ...11 Pause 2 11 Chapter 3 Setting up the Aspirator Before You Begin 3 1 Connect to an External Power Source 3 2 Attach the Collection Canister and Tubing 3 3 Using the Aspirator 3 4 Operational Test 3...

Page 5: ...nvironments 5 4 Alarm Types 5 4 Alarm Groups 5 5 High Priority Alarms 5 6 Medium Priority Alarms 5 8 Low Priority Alarms 5 9 Pop Up Messages 5 14 Notifications 5 14 Chapter 6 Operating in Harsh Enviro...

Page 6: ...6 Batteries 7 6 Collection Canister 7 6 Device 7 6 Appendix A Specifications General A 1 Device Classification A 3 Emissions and Immunity Compliance A 4 Basic Safety and Essential Performance A 6 App...

Page 7: ...ons regarding aspirator use A description of guide conventions An abbreviation and acronym list Information regarding FDA tracking requirements warranty and software license How to contact ZOLL Medica...

Page 8: ...ical damage or the aspirator does not pass its self test procedure U S A customers should call ZOLL Medical Corporation 1 978 421 9655 Customers outside of the U S A should contact the nearest ZOLL au...

Page 9: ...governing regulations regarding the disposal of any part of this medical device Serial Number Numbers following SN indicate the serial number BF Symbol Protection against electric shock Type B with fl...

Page 10: ...tion Symbol Description Alarm Bell Outline Identifies alarm limit settings Identifies the on screen alarms Alarm Bell Identifies the number of off screen alarms Attention High Priority Alarm Active Ca...

Page 11: ...external power source Internal Battery Provides indication of battery capacity and charging The number below the icon displays the percent of charge for the battery Indicates that an external battery...

Page 12: ...ife Support LPM Liters Per Minute AMC Alarm Message Center ml Milliliters APOD Advanced Probe Off Detection mm Millimeter ATPD Atmospheric Temperature and Pressure Dry mm Hg Millimeters of Mercury B V...

Page 13: ...an alarm is activated to guide the operator through on screen commands when responding to alarms Operating temperature range for extreme conditions 26 C to 55 C 14 8 to 131 F Warnings General The aspi...

Page 14: ...ion tubing and or catheters should be considered potentially hazardous Use proper Personal Protection Equipment and handle accordingly Electric shock hazard Do not remove equipment covers You may only...

Page 15: ...nator s organization Company name address contact name and contact phone number 2 Model number and serial number of the aspirator 3 Disposition of the aspirator for example received lost stolen destro...

Page 16: ...rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer and Licensors to ZOLL Medical Corporation and they do not pass to purchaser 3 Assignme...

Page 17: ...an accident Batteries which by their nature are consumable and subjected to environmental extremes will be warranted only for a period of ninety 90 days Accessories also consumable in usage such as su...

Page 18: ...from the service representative The Li ion battery should remain inside the device Follow directions provided on the return authorization form Pack the device with its cables in the original shipping...

Page 19: ...of intermittent cycles Note Also refer to ZOLL Model 330 Multifunction Aspirator Indications for Use in Chapter 1 for further information on aspirator applications Aspirator Description The ZOLL Model...

Page 20: ...d design Continuous and Intermittent modes Intuitive user interface Weight 9 9 lbs 3 to 8 hours of battery run time Rapid charging 90 battery capacity in 2 hours Standby Control Daylight visible displ...

Page 21: ...ter Status Indicator LED Array Top Lights up to indicate status of the device connected to alarms External Power Input Connector Top Connects the device to an external power source USB Connector Top C...

Page 22: ...ontrol 3 Main Menu button Displays the main menu 4 Encoder Dial Dial Changes the value of the highlighted parameter 5 Mute Cancel button Mutes audible alarm indicators cancels parameter entries and ex...

Page 23: ...control panel Alarms When an alarm occurs the Message Area displays Smart Help messages that identify the alarms possible causes and actions to take in response Alarms can obscure the Vacuum Gage but...

Page 24: ...Directly below the message area the device displays icons that indicate Power source external power or internal battery Battery Charge Status Alarm Muted Audible Alarm Priority Continuous Mode Range...

Page 25: ...lection canister is part of the pneumatic system It collects fluids and prevents patient waste from entering the aspirator The Vacuum Port is a 3 8 inch barbed port on the top of the aspirator Gas fro...

Page 26: ...Top Panel The aspirator s top panel appears in the figure below Collection Canister Typical use of the aspirator is with a single collection canister and lid as shown Warning Only use collection cani...

Page 27: ...ration or loss of any alarms When external power returns operating power automatically switches to the external power source In the event you need to shutdown turn the Power Switch to the OFF O positi...

Page 28: ...be mounted in either side of the aspirator Noise Power and Use Features The noise power and use features include Smart Flow Standby Pause Smart Flow The Smart Flow feature automatically detects when t...

Page 29: ...device status When standby is stopped by pressing the Standby button the aspirator immediately begins operation with the last settings Pause To minimize risk to the patient the device enters a Pause...

Page 30: ......

Page 31: ...irator to an external power source if available 2 Attach collection canister and tubing 3 Turn ON the aspirator 4 Perform an operational test We describe how to perform these tasks in the following se...

Page 32: ...tches Failure to do so may damage the power connection plug and prevent it from functioning Warning If there is damage to the power supply power cable or power connection plugs or they become damaged...

Page 33: ...ckaging for the patient tubing is damaged discard that tubing and use the tubing from an intact package An overflow protection float prevents aspiration of more fluid than the capacity of the collecti...

Page 34: ...the External Power icon should be present If the aspirator does not detect external power the External Power icon appears with a slash through it Check all power connections and ensure the power sourc...

Page 35: ...up messages to guide operation during normal use and when there is a fault or failure that affects device performance or safety Interface Overview The user interface allows the user to configure two...

Page 36: ...ice Buttons and Controls The location of all buttons and other controls are as shown in the figure below Rotary Encoder Dial Turning the Rotary Encoder Dial Dial clockwise and counterclockwise allows...

Page 37: ...an alarm is detected the alarm message displays as long as the alarm is active Pressing the Mute Cancel button acknowledges the alarm condition and allows the user 30 seconds to adjust settings The M...

Page 38: ...e Pressing the Main Menu button displays the following settings Initially the Power Up setting is always selected when the Main Menu opens The following settings can be accessed and set through the Ma...

Page 39: ...buttons are positioned on the right side of the device see Figure below The function of these buttons is dependent upon which suction mode is enabled on the aspirator Continuous or Intermittent and i...

Page 40: ...Using the Aspirator User Interface 4 6 www zoll com 906 0330 01 01 Rev D...

Page 41: ...tion in this chapter Note When Smart Flow is ON the pump is operating at a low speed Occlude the suction tubing to ensure that the collection system is intact and that the set vacuum level is reached...

Page 42: ...y is decreased for both to save power To set parameters for Continuous Mode see Continuous Mode Operation in this chapter To set parameters for Intermittent Mode see Intermittent Mode Operation in thi...

Page 43: ...allows you to control the following parameters Vacuum level ON Time OFF Time The Intermittent Mode vacuum range adult and pediatric initial vacuum level settings are CASS The Continuous Aspiration of...

Page 44: ...the threshold the vacuum pump increases its speed RPM to reach the intended vacuum level target When suctioning is removed the vacuum level drops below the threshold and the vacuum pump continues oper...

Page 45: ...ow describe Main Menu choices in greater detail Alarm Configuration Selecting the Alarm Configuration allows the operator to disable the audible and visible alarm alerts associated with specific alarm...

Page 46: ...highlight Power Up settings then press the Confirm button 3 If needed turn the Dial to highlight the Power Up choice then press the Confirm button which then presents the sub menu where Power Up is h...

Page 47: ...ise increases the contrast 4 Press the Main Menu button to leave the menu and have the aspirator enter Pause Note The contrast value is saved between uses This may require that the contrast value be r...

Page 48: ...tion SAM SW Rev The Smart Aspirator Module SAM software revision that is in use with the device SAM SN The serial number of the SAM SW Rev The aspirator user interface software revision that is in use...

Page 49: ...e to ensure that all of the systems are functioning as intended When the device detects a problem it triggers an alarm and displays a Smart Help message to the user The Smart Help message provides a m...

Page 50: ...ell appears When multiple alarms are active the number of bells corresponds to the number of alarms The solid alarm bell indicates the displayed alarm and its priority To view each active alarm turn t...

Page 51: ...s present an audible tone and the LED array is red It is distinguished from the high priority alarm by a slower pulse tones and LED flash rate Pressing the Mute Cancel button mutes medium priority ala...

Page 52: ...n audible alarm the LED alarm light and alarm message are still present Alarm Types The aspirator uses a series of alarm types to provide a framework for you to see the scope and range of the alarms t...

Page 53: ...Check Battery Battery Drained Battery Nearly Drained Battery Low Discharge Fault Too Hot Cold Ambient Pressure Low Sensor Failure External Power Current High DC Power Reversed High Low Disconnect Firm...

Page 54: ...matic Sensor Vacuum Pressure Manually Aspirate Patient Contact Service Center 1172 Self Check Failure Alarm occurs when the 5 volt power bus fails to provide the required voltage If this failure occur...

Page 55: ...begin operation with external power the device must be turned off and then back on Mitigation Info Manually Aspirate Patient Connect External Power Contact Service Center 1471 Self Check Failure Alarm...

Page 56: ...Failure Alarm occurs when the device detects a potential valve fault the vacuum level is not reduced during the intermittent mode of operation Mitigation Info Manually Aspirate Patient Contact Service...

Page 57: ...rent and higher temperatures Shading the patient and aspirator from direct sunlight may also help reduce the battery temperature Mitigation Info Temperature Within 5 C 41 F of High Limit Ensure Extern...

Page 58: ...ects an altitude 2 500 feet below sea level 610 meters 15 8 psig or 103 kPa This can be caused by use in subterranean rescue operation or mistaken use in a hyperbaric chamber Beyond this pressure leve...

Page 59: ...o Internal Battery Operation Check Power Connection Supply Monitor Battery Status Contact Service Center 3422 Battery Fault Alarm triggers when the internal battery has been removed or communication b...

Page 60: ...t When this fault occurs the device automatically switches to operation using the internal battery If the external power source is known to be good then the AC DC Power Supply may be faulty and need r...

Page 61: ...ry Charging Fault Alarm triggers when the battery temperature is 0 C 32 F Charging the battery below this temperature could destroy the battery and damage the device During the alarm condition the dev...

Page 62: ...tached to a patient In order to proceed you must press the Confirm button to begin the calibration procedure Attach accessories to aspirator before starting Smart Flow calibration Press the Accept key...

Page 63: ...extreme environments the unit alerts you with a Low Priority alarm which defines the operating condition and prompts your actions Low Priority alarms are advisory and you should remember that the dev...

Page 64: ...m limit as long as the ambient pressure makes operation at the maximum vacuum setting possible Maximum vacuum limit decreases with altitude When the operating altitude makes it impossible for the aspi...

Page 65: ...n its soft case and use the rain flap provided with the case The soft case and rain flap prevent water from puddling on the aspirator s surfaces To best protect the aspirator from rain and snow do the...

Page 66: ......

Page 67: ...insure compliance with operating specifications it is your responsibility to insure that periodic preventative maintenance is performed Only ZOLL trained and certified personnel should perform mainte...

Page 68: ...sives or chlorinated hydrocarbon based cleansers as they damage the plastic Post Contaminated Environment Cleaning If you have used the aspirator in an environment where it may have been exposed to co...

Page 69: ...d for approximately 1 second These false alarms immediately clear themselves While the unit is operating on battery power you can best determine the relative amount of charge in the internal battery b...

Page 70: ...tteries are removed Follow the battery storage recommendations that we describe in this chapter Following 6 months or longer of continuous storage inspect the device perform an Operational Test and re...

Page 71: ...the integrity of all accessories suction tubing and fitting connections Check all control panel settings and follow the alarm mitigation instructions provided by the aspirator s Smart Help messages V...

Page 72: ...nd patient ports on the collection canister lid with the attached port caps 3 Remove canister from the canister holder and transport to disposal area along with the suction tubing 4 Place the collecti...

Page 73: ...550 mm Hg Adjustable 60 to 400 mm Hg Adjustable 60 to 220 mm Hg Adjustable 10 to 40 mm Hg Intermittent Vacuum Range ON OFF Times Vacuum Level Adjustable 10 to 200 mm Hg ON OFF Times 5 to 40 seconds FR...

Page 74: ...ower supply cable that ZOLL provides with the device Operating Time Internal Battery 3 hours using settings defined in ISO 10079 1 2015 for battery operation testing Aspirator Temperature Ranges Opera...

Page 75: ...art BF Type B with floating F type parts Degree of Protection against Harmful Ingress of Water and solids Protection with soft case and rain flap IP33 Liquid Spraying water Solid 2 5mm diameter and gr...

Page 76: ...ansducers that are likely to affect product compliance Warning Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in in...

Page 77: ...fluctuations flicker emissions IEC 61000 3 3 Complies Immunity Test Test Level Compliance Level Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast...

Page 78: ...e with regard to electromagnetic disturbances for the expected service life Perform preventive maintenance on the device on an annual basis Follow service procedures as defined in the service manual t...

Page 79: ...9141 000127 Assembly AC DC Power Supply Plug without output connector 708 0042 00 AC Power line cord 6 United States Version 704 0EMV 06 Automotive Cable 703 0731 01 Battery Pack Li ion Aspirator Acce...

Page 80: ...Accessories B 2 www zoll com 906 0330 01 01 Rev D Other 800 0904 01 CCLAW Critical Care Litter Attachment Widget Mounting Bracket 800 0903 01 SMEED Part Number Part Description...

Page 81: ...ce In Silent Dark mode the aspirator Suppresses the audible alarm Suppresses the back lights for the LCD display and the Confirm and Mute Cancel buttons Emits only infrared light for the alarm LED ind...

Page 82: ...Menu so that the operator can enter Silent Dark mode at a later time for the duration of the current power cycle 2 When aspirating in Silent Dark mode the operator should be extremely diligent in moni...

Page 83: ...age 7 4 C Cautions 1 8 1 9 Cleaning the Aspirator 7 2 general cleaning 7 2 post contaminated environments 7 2 suction canister and tubing 7 2 Clinical Applications 2 1 Collection Canister 3 3 Collecti...

Page 84: ...to alarms 5 1 5 3 Software License 1 10 Specifications A 1 A 6 basic safety A 6 device classification A 3 essential performance A 6 general A 1 A 2 Starting the Aspirator 4 7 Storage aspirator 7 4 bat...

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