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Page

B-7

User Guide

Electromagnetic Immunity Declaration (EID)

Table B-7

Guidance and Manufacturer’s declaration – Electromagnetic immunity for Platform

The Platform is intended for use in the electromagnetic environment specified below. The customer or user of the
Platform should ensure that it is used in such an environment.

Immunity test

IEC 60601 Test Level

Compliance Level

Electromagnetic
environment – guidance

Electrostatic Discharge
(ESD) IEC 61000-4-2

± 8 kV contact
± 15 kV air

Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be at
least 30%

Electrical fast transient/burst
IEC 61000-4-4

Not Applicable

No mains power connection

Surge IEC 61000-4-5

Not Applicable

No mains power connection

Voltage dips, short
interruptions, and voltage
variations on power supply
input lines IEC 61000-4-11

Not Applicable

No mains power connection

Power frequency (50/60 Hz)
magnetic field. IEC 61000-
4-8

30 A/m

Power frequency magnetic
fields should be at levels
characteristic of typical
location in a typical
commercial or hospital
environment.

Содержание AutoPulse 100

Страница 1: ...P N 12555 001 Rev 9 Resuscitation System Model 100 User Guide...

Страница 2: ...his publication may be reproduced stored in a retrieval system or transmitted in any form or by any means mechanical electronic photocopying recording or otherwise without prior written permission of...

Страница 3: ...4 2 3 Menu Mode Switch Button 1 6 1 4 2 4 Move Up Move Down Button 1 6 1 4 2 5 Select Choice Button 1 7 1 4 2 6 Tone Mute Button 1 7 1 4 2 7 Increase Decrease Contrast Button 1 8 1 4 2 8 Power Green L...

Страница 4: ...3 4 4 Maintenance 4 3 4 5 Disposal and Recycling 4 5 4 5 1 Platform 4 5 4 5 2 Battery Charger 4 5 4 5 3 Batteries 4 5 4 5 4 LifeBand 4 5 5 Troubleshooting Procedures 5 1 5 1 Troubleshooting Batteries...

Страница 5: ...ure 2 14 Compression Mode Menu 2 12 Figure 2 15 Mute Duration Menu 2 13 Figure 2 16 Ventilation Pause Tone Volume Menu 2 14 Figure 2 17 Continuous Mode Ventilation Tone Menu 2 15 Figure 3 1 On Off But...

Страница 6: ...en 3 22 Figure 4 1 Battery Charger with Charging Bay 4 1 Figure 4 2 Battery Charger Control Panel 4 2 Figure 5 1 Low Battery Warning 5 1 Figure 5 2 Replace Battery Screen 5 2 Figure 5 3 A User Advisor...

Страница 7: ...l Specifications B 2 Table B 4 Li Ion Battery Specifications B 2 Table B 5 Battery Charger Specifications B 4 Table B 6 Guidance and Manufacturer s Declaration Electromagnetic Emissions B 6 Table B 7...

Страница 8: ...Page viii User Guide This page left intentionally blank...

Страница 9: ...uscitation CPR General Warnings and Precautions 0 Warning The AutoPulse System is intended for use on adults 18 years of age or older The AutoPulse System is not intended for patients with traumatic i...

Страница 10: ...ce should be reported to the manufacturer and the competent authority of the Member State in which the user and or patient is established Warning If a user advisory or fault cannot be cleared or a sys...

Страница 11: ...ons for use Date of Manufacture Manufacturer Authorized Representative Serial Number Defibrillation Protected Type BF Patient Connection Degree of Protection Provided by Enclosure Per IEC 60529 Do Not...

Страница 12: ...Page xii User Guide Do Not Incinerate Fuse DC Voltage Caution Charging Ready Fail Test Cycle Power Caution Catalog number Prescription use only Importer Medical device REF Rx ONLY MD...

Страница 13: ...ntended to reduce the impact of rescuer fatigue and will enable the rescuer to address additional patient needs The AutoPulse System has the following operating parameters Chest displacement equal to...

Страница 14: ...anism control system and electronics necessary to generate and control the force required to perform mechanical chest compressions User controls and indicators are contained in the User Control Panel...

Страница 15: ...contact with the patient 1 3 3 AutoPulse Power System The AutoPulse Power System consists of a battery and battery charger Battery the AutoPulse Li Ion Battery a Lithium Ion battery Battery charger t...

Страница 16: ...e On Off button is located adjacent to the Battery on the Platform see Figure 1 3 Figure 1 3 On Off Button Location 1 4 1 1 On Off Button 1 4 2 User Controls All user controls and indicators except th...

Страница 17: ...ge Stop Cancel button is active when Stop Quit or Cancel appears on the display panel above the button and its orange LED is illuminated Use the Stop Cancel button to stop or cancel Analyzing patient...

Страница 18: ...his button may function as the Mode Switch button The Mode Switching feature is only active when the 30 2 or Continuous or 15 2 or Continuous option has been set in Mode section of the Administration...

Страница 19: ...ble pressing the Tone Mute button will mute it When the audio feedback is muted pressing the Tone Mute button will make it audible once again Once audio feedback has been muted with the Tone Mute butt...

Страница 20: ...charge status icon only appears when the Platform is powered up Pressing the Increase Contrast button plus sign increases the contrast of the display panel screen Each key press increases the contras...

Страница 21: ...by two beeps every 30 seconds until the battery is replaced or depleted It is recommended that if available a fully charged Battery be exchanged for the Battery with the low charge To exchange Batter...

Страница 22: ...harge Be prepared to exchange this Battery with a fully charged Battery Two bars showing The Battery s capacity is between 33 and 66 of a full charge Three bars showing The Battery s capacity is betwe...

Страница 23: ...n a smooth flat surface Note The driveshaft should be oriented so that the slot faces directly upward 3 Insert the head end of the LifeBand band clip into the driveshaft slot The correct direction is...

Страница 24: ...nd Band Clip Properly into the Driveshaft Slot 6 Ensure that both free ends of the LifeBand are oriented flat not twisted and away from the AutoPulse Platform Inspect the LifeBand for any cuts or tear...

Страница 25: ...nto Place 9 Flip down and snap into place the hinged belt guards of the LifeBand cover plate to engage the LifeBand chest bands to the rollers see Figure 2 4 Figure 2 4 Flip Down the Hinged Belt Guard...

Страница 26: ...fore removing it from the Platform Cutting the LifeBand may cause the Platform to report a Fault and will require specific steps to clear that Fault 1 Place the Platform with the patient surface facin...

Страница 27: ...ide 3 Using both hands pinch together the locking tabs of the LifeBand cover plate and firmly pull the plate straight up and away from the Platform see Figure 2 6 Figure 2 6 Pinching the Locking Tabs...

Страница 28: ...after patient use Treat the LifeBand as contaminated medical waste and dispose of it accordingly There are no user serviceable parts Warning Removing the band clip when the driveshaft is not at its ho...

Страница 29: ...d is installed a shaft lock mechanism secures the driveshaft in the Home Position do not attempt to defeat the shaft lock mechanism Figure 2 8 LifeBand NOT in the Home Position Do Not Remove Removing...

Страница 30: ...on either side of the driveshaft and pull both bands outward Figure 2 10 LifeBand in the Home Position Ready for Removal 2 The chest bands should now be fully extended The seam securing the band clip...

Страница 31: ...can slide into the Battery compartment see Figure 2 11 Then slide the Li Ion Battery into the Battery compartment in the Platform The Li Ion Battery should snap into place and mount flush with the Pl...

Страница 32: ...Ion Battery to be pulled straight out until it fully clears the Battery compartment Caution Only use ZOLL Batteries specifically designed for use with the Platform The use of other batteries may caus...

Страница 33: ...e the Administrative Menu is active use the Move Up and Down arrow buttons to highlight the desired menu item and the Select Choice Button to select it Figure 2 13 Administrative Menu scrolled down AD...

Страница 34: ...between 30 2 and continuous compressions or 15 2 and continuous compressions respectively while the system is actively doing compressions Selecting 30 2 Only or 15 2 Only will restrict the system ope...

Страница 35: ...wo minutes Highlight the desired setting using the Move Up and Down arrow buttons press the Select Choice Button to select it a check will appear beside the selected item and then press the gray Menu...

Страница 36: ...rator that the system has been deliberately stopped paused while actively doing compressions Choices are High and Low Highlight the desired setting using the Move Up and Down arrow buttons press the S...

Страница 37: ...ate the patient Selecting 3 Beeps will allow for three ventilation tones to sound as a countdown to cue the rescuer to ventilate the patient after the third ventilation tone Highlight the desired sett...

Страница 38: ...Page 2 16 User Guide This page left intentionally blank...

Страница 39: ...racing is suggested for roles and positions of the staff involved in performing defibrillation and using the AutoPulse System Your local ZOLL representative can provide you with appropriate detailed...

Страница 40: ...Self Test Display Panel Screen 3 The Platform indicates that it is ready for use see Figure 3 3 Figure 3 3 Patient Readiness Display Panel Screen 30 2 I n i t i a l i z i n g 30 2 m e n u CONTINUE A l...

Страница 41: ...he local protocol calls for anterior posterior placement Use of standard pads in both the a p or anterior anterior apex sternum placement is acceptable and will not affect the operation of the Platfor...

Страница 42: ...thing by the sleeves and pull down toward the ankles to remove all of the clothing from both the front and back of the torso see Figure 3 5 The anterior pad s may be placed at this time Figure 3 5 Rem...

Страница 43: ...platform as shown in Figure 3 6 Figure 3 6 Correct Patient Alignment Warning Do not place or position the patient on the Platform in either a facedown orientation or on the patient s side Also ensure...

Страница 44: ...slot of band 2 over the alignment tab 1 see Figure 3 7 c Press the bands together to engage and secure the Velcro fastener see Figure 3 8 d Lift up the LifeBand to its fullest extension ensuring that...

Страница 45: ...here are no obstructions such as clothing straps or equipment with the bands Warning Failure to properly position the LifeBand at the patient s armpit line may cause injury to the patient Failure to p...

Страница 46: ...en up any slack in the bands see Figure 3 10 If the patient is not properly aligned press the Stop Cancel button realign the patient and begin compressions again with step 1 on page 3 7 Warning Do not...

Страница 47: ...immediately initiate compressions ahead of that time Warning Do not lean on the patient after pressing the Start Continue button If you must move or realign the patient you must press the Stop Cancel...

Страница 48: ...Mode setting within the Administrative Menu then the Platform will perform in the mode either 15 2 or Continuous that was used last until powered down on power up 15 2 will be the initial selection I...

Страница 49: ...creen Note Positive pressure ventilation can be performed synchronously with any decompression and or during the ventilation pause Warning Check the patient s chest rise during ventilation during acti...

Страница 50: ...firm that the mode change has been accepted 7 To access the patient or to pause the Platform for any reason press the Stop Cancel button The Platform releases the tension on the LifeBand allowing the...

Страница 51: ...ntinue Compressions Display Panel Screen 8 To restart compressions press the CONTINUE button as described in the procedure starting at step 1 on page 3 7 see Figure 3 15 30 2 S t o p p i n g 30 2 Q U...

Страница 52: ...Refer to Section 4 2 Cleaning the Platform for more information 4 Replace the LifeBand before returning the Platform to service Refer to Section 2 1 1 Installing the LifeBand for more information 5 R...

Страница 53: ...ing the patient lift by supporting the patient and the Platform onto the transportation device for example a gurney backboard AutoPulse Quick Case or AutoPulse Soft Stretcher and place the Platform an...

Страница 54: ...ended Method of Patient Extrication This extrication method includes the AutoPulse Shoulder Restraint Head Immobilizer and Soft Carry Stretcher Figure 3 16 Securing the Patient for Transport ON OFF He...

Страница 55: ...g moving around tight corners and stairwells The Platform may also be secured to a backboard using standard straps or backboard cable ties Always ensure the following 1 Make sure that the patient s ar...

Страница 56: ...r Administrative Menu is active use the Move Up and Down arrow buttons to highlight the desired menu item and the Select Choice Button to select it Information presented about the Last Patient session...

Страница 57: ...from the platform Currently the platform will upload the patient information from at least the last three patient sessions and potentially many more depending on the length of the resuscitation effor...

Страница 58: ...Alternatively you may enter directly into the Communication Mode by depressing the Menu Mode Switch button as you power up the platform Figure 3 19 Infrared Communication Set up 4 Aim the host compute...

Страница 59: ...ction panel screen is displayed If a connection can not be established within ten minutes the Platform will automatically power down Figure 3 21 Connected Display Panel Screen 6 When a connection is e...

Страница 60: ...complete the panel screen will return to the Connected display see Figure 3 21 If while transmitting data the Platform loses communication with the host computer it will automatically try to reestabl...

Страница 61: ...ry Charger Note If a Li Ion Battery s internal temperature is below a nominal 41 F 5 C the Battery will fail to charge in the Battery Charger If a Battery is retrieved from cold storage or extensive e...

Страница 62: ...ving a Battery during a Test Cycle will cause the Battery Charger to automatically enter a Test Cycle mode the next time the Battery is inserted into it 5 To remove a Battery from the Battery Charger...

Страница 63: ...parts nor does the device require regular maintenance There are no components that require calibration Users should periodically inspect the AutoPulse system to ensure the device s functionality In ca...

Страница 64: ...Battery Charge Status Icon on the Platform User Control Panel should also be visible with 4 bars if not replace the Battery with a fully charged Battery from the Battery Charger 5 If the Platform RED...

Страница 65: ...g plans for electronic waste 4 5 2 Battery Charger Dispose of in accordance with local governing ordinances and recycling plans for electronic waste 4 5 3 Batteries Do not throw your batteries away or...

Страница 66: ...Page 4 6 User Guide This page left intentionally blank...

Страница 67: ...ll be accompanied with an audio warning of four rapid beeps which will be followed by two beeps every 30 seconds until the battery is replaced or depleted If operation continues without changing the B...

Страница 68: ...llow these general steps to troubleshoot Advisories and Faults 1 Check for correct patient alignment refer to Section 3 1 Deploying the AutoPulse System for more information fully extend LifeBand and...

Страница 69: ...latform information menu refer to section Section 3 7 Viewing Platform Information on page 3 18 Figure 5 3 A User Advisory Screen Figure 5 4 A Fault Screen 30 2 m e n u RESTART P u l l u p L i f e B a...

Страница 70: ...978 421 9655 Warning Removing the band clip when the driveshaft is not at its home position see Figure 2 8 on page 2 7 will result in a permanent User Advisory 45 that the user will not be able to cl...

Страница 71: ...s to return the Platform to normal operation The Platform has detected an unrecoverable problem and cannot be restarted Therefore you must 1 Begin manual CPR immediately 2 Contact ZOLL at 1 800 348 90...

Страница 72: ...Page 5 6 User Guide This page left intentionally blank...

Страница 73: ...WER LED will remain lit The Battery Charge Status Icon on the Platform User Control Panel should also be visible with 4 bars if not replace Battery with a fully charged Battery from the Battery Charge...

Страница 74: ...Page A 2 User Guide This page left intentionally blank...

Страница 75: ...The AutoPulse System is intended for use on adults 18 years of age or older Table B 1 Operating Parameters Category Specifications Chest displacement Equal to 20 reduction in anterior posterior chest...

Страница 76: ...ts IEC 61000 4 2 6 KV Contact 8 KV Air Electromagnetic emissions Meets CISPR 11 EN55011 Group 1 Class A Patient contacting materials Meets ISO 10993 1 Biological evaluation of medical devices Shock Me...

Страница 77: ...ks starting with a fully charged Battery Operating altitude 0 to 15 000 ft 0 to 4 572 m Enclosure protection Meets IP24 per IEC 60529 Shock Meets IEC 60068 2 27 Basic Environmental Testing Procedures...

Страница 78: ...nsport temperature 40 to 158 F 40 to 70 C Relative humidity 5 to 95 non condensing Operating altitude 0 to 10 000 ft 0 to 3 048 m Enclosure protection Meets IP22 per IEC 60529 Shock Meets IEC 60068 2...

Страница 79: ...rmance of this device To mitigate disruptive electromagnetic interference position this device away from radio frequency transmitters and other sources of electromagnetic energy Dips interruptions and...

Страница 80: ...rnal function only Therefore its RF emissions are very low and are not likely to cause any interference in nearby equipment RF Emissions CISPR 11 Class A The Platform is suitable for use in all establ...

Страница 81: ...tact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electricalfasttransient burst IEC 61000 4 4 Not...

Страница 82: ...d 0 35 P 80 to 800 MHz d 0 7 P 800 MHz to 2 7 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 separatio...

Страница 83: ...bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24...

Страница 84: ...rs and cables other than those specified by the manufacturer may result in increased Emissions or decreased Immunity of the AutoPulse System The AutoPulse System should be observed to verify normal op...

Страница 85: ...request repair or replacement under this warranty Purchaser should contact ZOLL Circulation Inc 2000 Ringwood Avenue San Jose CA 95131 1 408 541 2140 main 1 408 541 1030 fax ZOLL Circulation will inf...

Страница 86: ...THE ACTUAL PAYMENTS RECEIVED BY ZOLL CIRCULATION IN CONNECTION THEREWITH ZOLL CIRCULATION SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE INCLUDING WITHOUT LIMIT...

Страница 87: ...apacity B 3 charge time B 3 specifications B 2 test cycle time B 3 Battery charge icon 1 10 Battery charge status 1 8 button increase decrease contrast 1 8 C Chest bands See Lifeband Chest Compression...

Страница 88: ...3 15 patient AutoPulse Platform positioning 3 5 performance characteristics 1 10 physical specifications B 4 physiological duty cycle 1 1 B 1 Platform environmental specifications B 2 Platform operati...

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