Model DDU-100 Semi ADU User Manual Software V2.0

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U S E O N LY I F PA T I E N T I S : UNCONSCIOUS UNRESPONSIVE N O T B R E AT H I N G

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PUSH "ON" BUTTON

FOLLOW VOICE PROMPTS

IF INSTRUCTED, PUSH "SHOCK" BUTTON

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Notices Defibtech shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Information in this document is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted.

Limited Warranty The “Limited Warranty” shipped with Defibtech AED products serves as the sole and exclusive warranty provided by Defibtech, LLC with respect to the products contained herein.

Copyright Copyright © 2010 Defibtech, LLC. All rights reserved. Copyright questions should be directed to Defibtech. For contact information, refer to the “Contacts” section of this manual.

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician

Contents 1 Introduction to the DDU-100 Series AED... 1 1.1 1.2 1.3 1.4 1.5

Overview... 1 The Defibtech DDU-100 AED... 2 Indications... 4 Contraindications... 4 Operator Training Requirements... 4

2 Dangers, Warnings and Cautions... 5 2.1 Shock, Fire Hazard, Explosion... 5 2.1.1 Electricity... 5 2.1.2 Battery Pack... 5 2.1.3 Usage Environment... 6 2.1.4 Defibrillation/Shock Delivery... 6 2.1.5 Maintenance... 7 2.2 Improper Device Performance... 7 2.2.1 Usage Environment... 7 2.2.2 Pads... 8 2.2.3 Patient Analysis... 8 2.2.4 Shock Delivery... 9 2.2.5 Maintenance... 9 2.3 General... 9 3 Setting up the DDU-100 AED... 11 3.1 3.2 3.3 3.4 3.5 3.6 3.7

Overview... 11 Installing the Data Card... 12 Installing the Active Status Indicator 9V Battery... 12 Installing and Removing the Battery Pack... 13 Connecting the Pads... 14 Performing Manually Initiated Self-Tests... 15 Storing the DDU-100 AED... 15

4 Using the DDU-100 AED... 17 4.1 Overview... 17 4.2 Checking DDU-100 AED Status... 18 4.3 Turning on the DDU-100 AED... 18

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4.4 Preparation... 19 4.4.1 Call for Help... 19 4.4.2 Preparing the Patient... 19 4.4.3 Opening the Pad Package... 19 4.4.4 Connecting Defibrillation Pads to the DDU-100 AED... 19 4.4.5 Applying Pads to the Patient... 20 4.4.6 Follow DDU-100 AED Prompts... 21 4.5 Heart Rhythm Analysis... 22 4.6 Delivering the Shock... 23 4.7 No Shock Required... 24 4.8 Post-Shock CPR... 25 4.9 Post Use Procedures... 26 4.10 Operational Environment... 26 5 Maintaining and Troubleshooting the DDU-100 AED... 27 5.1 Self-Tests... 27 5.2 Routine Maintenance... 28 5.2.1 Checking Active Status Indicator... 28 5.2.2 Checking the Condition of the Unit and Accessories... 29 5.2.3 Running a Manually Initiated Self-Test... 29 5.2.4 Replacing Pads ... 30 5.2.5 Checking Pad and Battery Pack Expiration Dates... 30 5.2.6 Checking the DDC If One Was Installed... 31 5.3 Replacing the Lithium 9V ASI Battery... 31 5.4 Cleaning... 32 5.5 5.6 5.7 5.8

Storage... 32 Operator’s Checklist... 33 Troubleshooting... 34 Repair... 36

6 DDU-100 AED Accessories... 37 6.1 Defibrillation/Monitoring Pads... 37 6.2 Battery Packs... 37 6.2.1 Battery Pack Active Status Indicator... 38 6.2.2 Active Status Indicator Battery... 38 6.3 Data Cards... 38 6.4 Recycling Information... 39 6.4.1 Recycling Assistance... 39 6.4.2 Preparation... 39 6.4.3 Packaging... 39 6.4.4 Notice to European Union Customers . ... 40

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7 Event Viewing... 41 7.1 Defibtech Data Cards... 41 7.2 Downloading the Internal Data Log... 42 8 Technical Specifications... 43 8.1 Defibtech DDU-100 AED... 43 8.1.1 Physical... 43 8.1.2 Environmental... 43 8.1.3 Defibrillator... 44 8.1.4 Waveform Specifications... 44 8.1.5 Patient Analysis System... 45 8.1.5.1 Shockable Rhythm Criteria... 46 8.1.5.2 Patient Analysis System Performance... 47 8.1.6 Clinical Summary... 47 8.1.6.1 Background... 47 8.1.6.2 Methods... 48 8.1.6.3 Results... 48 8.1.6.4 Conclusion ... 48 8.1.7. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity... 49 8.2 Battery Packs... 52 8.2.1 High-Capacity Lithium Battery Pack... 52 8.2.2 Standard Lithium Battery Pack... 52 8.3 Self-Adhesive Defibrillation/Monitoring Pads... 53 8.4 Defibtech Data Cards (DDCs)... 53 8.5 DefibView... 54 9 Glossary of Symbols... 55

10 Contacts... 57

11 Warranty Information... 59

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1 Introduction to the DDU-100 Series AED This User Manual provides information to guide trained operators in the use and maintenance of the Defibtech DDU-100 series Semi-Automatic External Defibrillator (“AED”) and its accessories. This chapter includes an overview of the AED, a discussion of when it should and should not be used, and information on required operator training.

1.1

Overview

The DDU-100 AED is a Semi-Automatic External Defibrillator (“AED”) that is designed to be easy to use, portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The DDU-100 AED is capable of recording event information including ECG, audio data (optional), and SHOCK/NO-SHOCK recommendations. When connected to a patient who is unconscious and not breathing, the DDU-100 AED performs the following tasks: • • • •

Prompts the operator to take necessary actions to enable analysis. Automatically analyzes the patient’s ECG. Determines whether a shockable rhythm is present. Charges the defibrillation capacitor and arms the SHOCK button if the AED detects a shockable rhythm. • Prompts the operator to press the SHOCK button when the device is ready and a shock is recommended. • Delivers a shock once the device has determined a shock is required and the SHOCK button has been pressed. • Repeats the process if additional shocks are required. The Defibtech DDU-100 AED will NOT shock a patient automatically; it will only advise the operator. The SHOCK button is enabled only when a shockable rhythm is detected and the device is charged and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must press the SHOCK button to initiate defibrillation. The DDU-100 AED uses two self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are provided in a single-use, disposable package. The DDU-100 AED determines proper pad-to-patient contact by monitoring the impedance between the two pads (impedance varies with the electrical resistance of the patient’s body). Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual



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indicators communicate the status of the AED and of the patient to the operator. The DDU-100 AED has two push-button controls and several LED indicators. Defibrillation energy is delivered as an impedance compensated biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load when using adult pads or when using attenuated child / infant pads, 50J of defibrillation energy into a 50-ohm load. Energy delivered does not change significantly with patient impedance, although the duration of the generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 – 180 ohms or 50J of defibrillation energy when using the child / infant pads. Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) lithium battery pack that provides for long standby life and low maintenance operation. Battery packs are available in several configurations optimized for use in specific applications. Each pack is marked with an expiration date. The DDU-100 AED records event documentation internally and, optionally, on Defibtech Data Cards (“DDC”). The optional DDC plugs into a slot in the AED and enables the AED to record event documentation, and audio (audio enabled cards only) if sufficient space is available on the card. Audio recording is available only for units with installed audio-enabled Defibtech Data Cards. Event documentation stored internally can be downloaded onto a DDC for review.

1.2

The Defibtech DDU-100 AED

A. Speaker. The speaker projects the voice prompts when the DDU-100 AED is on. The speaker also emits a “beep” when the unit is in standby mode and has detected a condition that requires operator attention. B. SHOCK button. This button will flash when a shock is recommended - push this button to deliver the shock to the patient. This button is disabled at all other times. C. “analyzing” LED (Light Emitting Diode). This green LED flashes when the DDU-100 AED is analyzing the patient’s ECG rhythm. D. “do not touch patient” LED. This red LED flashes when the DDU-100 AED detects motion or other interference that prevents analysis of the signal or when the user should not be touching or moving the patient. E. “check pads” LED. This red LED flashes when the DDU-100 AED detects that the pad connection to the patient is poor or pads are not applied. 

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F. ON/OFF button. Push button to turn the DDU-100 AED on. Push again to disarm and turn the AED off.

G. Pads connector port. Insert Patient Pads Connector (item O) into this port to connect pads to DDU-100 AED. H. Battery pack. The battery pack provides a replaceable main power source for the DDU-100 AED. I. Battery pack opening. Insert the battery pack firmly into this opening until the latch clicks into place. J. Battery pack eject button. This button releases the battery pack from the DDU-100 AED. To remove the battery pack, push the button until the battery pack is partially ejected from the unit. K. Active Status Indicator (ASI). When the unit is off, this indicator blinks green to indicate the unit is fully operational and blinks red to indicate unit needs attention from the user or servicing. L. Patient pads. The defibrillation/monitoring pads that are placed on the patient. The pads may be stored in the pad storage area on the back of the unit. M. Defibtech Data Card (DDC). This optional plug-in card provides enhanced storage capabilities to the DDU-100 AED. N. Active Status Indicator (ASI) battery. This is a 9V lithium battery that provides power to the Active Status Indicator. It is inserted into a compartment in the battery pack. O. Patient pads connector. Insert into Pads Connector Port (item G) to connect pads to the DDU-100 AED.

A

B

C

D

E

F

G K

L

M

N J I H O 

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1.3

Indications

The DDU-100 AED is indicated for use on victims of sudden cardiac arrest (“SCA”) when the patient is: • Unconscious and unresponsive. • Not breathing. For patients under 8 years old, use child/ infant electrode pads. Do not delay therapy to determine exact age or weight. The DDU-100 AED must be used by or on the order of a physician.

1.4

Contraindications

The DDU-100 AED should not be used if the patient shows any of the following signs: • Conscious and/or responsive. • Breathing. • Has a detectable pulse.

1.5

Operator Training Requirements

In order to safely and effectively operate the DDU-100 AED, a person shall have met the following requirements: • Defibtech DDU-100 AED and/or defibrillation training as required by local, state, provincial, or national regulations. • Any additional training as required by the authorizing physician. • Thorough knowledge and understanding of the material presented in this User Manual.



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2 Dangers, Warnings and Cautions This chapter includes a list of danger, warning, and caution messages that relate to the Defibtech DDU-100 AED and its accessories. Many of these messages are repeated elsewhere in this User Manual and on the DDU-100 AED or accessories. The entire list is presented here for convenience.

DANGER:

Immediate hazards that will result in serious personal injury or death.

WARNING:

Conditions, hazards, or unsafe practices that may result in serious personal injury or death.

CAUTION:

Conditions, hazards, or unsafe practices that may result in minor personal injury, damage to the DDU-100 AED, or loss of data.

2.1

Shock, Fire Hazard, Explosion

2.1.1 Electricity

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Hazardous electrical output. This equipment is for use only by qualified personnel.

2.1.2 Battery Pack

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CAUTION

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WARNING

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WARNING

Follow all battery pack labeling instructions. Do not install battery packs after the expiration date.

Lithium battery packs are not rechargeable. Any attempt to recharge a lithium battery pack may result in fire or explosion. Do not immerse battery pack in water or other liquids. Immersion in fluids may result in fire or explosion.



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Do not attempt to recharge, short-circuit, puncture, or deform battery. Do not expose battery to temperatures above 50°C (122°F). Remove battery when depleted.

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Recycle or dispose of lithium battery packs in accordance with federal, state, and/or local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.

WARNING

CAUTION

2.1.3 Usage Environment

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DANGER

Possible explosion hazard if used in the presence of flammable anesthetics or concentrated oxygen.

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The DDU-100 AED has not been evaluated or approved for use in hazardous locations as defined in the National Electric Code standard. In compliance with IEC classification the DDU-100 AED is not to be used in the presence of flammable substance/air mixtures.

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Do not immerse any portion of this product in water or other fluids. Do not allow fluids to enter the device. Avoid spilling any fluids on this device or accessories. Spilling fluids into the DDU-100 AED may damage it or present a fire or shock hazard. Do not autoclave or gas sterilize the DDU-100 AED or its accessories.

DANGER

CAUTION

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CAUTION

The DDU-100 AED should be stored and used only within the range of environmental conditions specified in the technical specifications.

2.1.4 Defibrillation/Shock Delivery

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WARNING



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Defibrillation current can cause operator or bystander injury. Do not touch the patient during defibrillation. Do not touch equipment connected to the patient or metal objects in contact with the patient during defibrillation. Disconnect other electrical equipment from the patient before defibrillating. Disconnect the DDU100 AED from the patient prior to use of other defibrillators.

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Improper use can cause injury. Use the DDU-100 AED only as instructed in the User Manual. The DDU-100 AED delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly. Do not discharge with defibrillation pads touching or gel surface exposed.

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Disconnect all non-defibrillator proof equipment from the patient before defibrillation to prevent electrical shock hazard and potential damage to that equipment.

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Avoid contact between parts of the patient’s body and conductive fluids such as water, gel, blood or saline, and metal objects, which may provide unwanted pathways for defibrillating current.

WARNING

WARNING

CAUTION

2.1.5 Maintenance

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WARNING

2.2

Electrical shock hazard. Dangerous high voltages and currents are present. Do not open unit, remove covers, or attempt repair. There are no user serviceable components in the DDU-100 AED. Refer servicing to qualified service personnel.

Improper Device Performance

2.2.1 Usage Environment

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Radio frequency (RF) interference from RF devices such as cellular phones and two-way radios can cause improper AED operation. In accordance with IEC 801.3, a distance of 2 meters (6 feet) between RF devices and the DDU100 AED is recommended.

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Although the DDU-100 AED is designed for a wide variety of field use conditions, rough handling beyond specifications can result in damage to the unit.

WARNING

CAUTION



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2.2.2 Pads

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Use only Defibtech disposable self-adhesive defibrillation/monitoring pads, battery packs, and other accessories supplied by Defibtech or its authorized distributors. Substitution of non-Defibtech approved accessories may cause the device to perform improperly.

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Follow all defibrillation pad label instructions. Use defibrillation pads prior to their expiration date. Do not re-use defibrillation pads. Discard defibrillation pads after use (in the event of suspected pad malfunction, return pads to Defibtech for testing).

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The defibrillation pads are intended for one time use only and must be discarded after use. Reuse can lead to potential cross infection, improper performance of the device, inadequate delivery of therapy and/or injury to the patient or operator.

WARNING

CAUTION

WARNING

2.2.3 Patient Analysis

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Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads. Replace the defibrillation pads if they become damaged during use.

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CPR rates above the American Heart Association guidelines of 100 BPM (beats per minute) can cause incorrect or delayed diagnosis by the patient analysis system.

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Do not place adult defibrillation pads in the anterior-posterior (front-back) position. A shock or no shock decision may be inappropriately advised. The DDU-100 AED requires that the adult defibrillation pads be placed in the anterioranterior (front-front) position.

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Some very low amplitude or low frequency rhythms may not be interpreted as shockable VF rhythms. Also some VT rhythms may not be interpreted as shockable rhythms.

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Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis, especially if very low amplitude or low frequency rhythms are present. During analysis and from “Shock Advised” until “Shock Delivered,” patient movement and vibration must be minimized.

WARNING

WARNING

WARNING

WARNING



WARNING

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WARNING

In patients with cardiac pacemakers, the DDU-100 AED may have reduced sensitivity and not detect all shockable rhythms. If you know the patient has an implanted pacemaker, do not place electrodes directly over an implanted device.

2.2.4 Shock Delivery

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Do not allow defibrillation pads to touch each other, or to touch other ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart.

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During defibrillation, air pockets between the skin and defibrillation pads can cause patient skin burns. To help prevent air pockets, make sure self-adhesive defibrillation pads completely adhere to the skin. Do not use dried out or expired defibrillation pads.

WARNING

WARNING

2.2.5 Maintenance

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WARNING

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WARNING

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CAUTION

2.3

Periodic user-initiated and automatic self-tests are designed to assess the DDU-100 AED’s readiness for use. However, no degree of testing can assure performance or detect abuse, damage, or a defect that occurred after the most recent test is completed. Use of damaged equipment or accessories may cause the device to perform improperly and/or result in injury to the patient or operator.

Improper maintenance can cause the DDU-100 AED not to function. Maintain the DDU-100 AED only as described in this User Manual. The AED contains no user serviceable parts – do not take the unit apart.

General

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Federal law (USA) restricts this device to sale by or on the order of a physician.



CAUTION

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3 Setting up the DDU-100 AED This chapter describes the steps required to make your Defibtech DDU-100 AED operational. The DDU-100 AED is designed to be stored in a “ready” state. This chapter tells you how to make the device ready, so that if and when you need it, few steps are required to begin using the device.

3.1

Overview

The following components and accessories are included with your DDU-100 AED. Replacement and other accessories are detailed in the “DDU-100 AED Accessories” section. Before getting started, identify each component and ensure that your package is complete.

• DDU-100 AED

• Battery pack

• 9V lithium battery

• Defibtech Data Card (DDC) (optional)

Defibtech DDU-100 Semi-Automatic External Defibrillator

• Defibrillation pad package

• User Manual

User Manual



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3.2

Installing the Data Card The Defibtech Data Card (“DDC”) is used to store event and audio information collected by the AED. All DDU-100 AEDs will operate without DDCs and will still store critical event information internally. Different DDC versions store different amounts of information. DDCs are available in versions that store and don’t store audio information. Refer to the DDC technical specification for exact storage capabilities. DDCs may be reviewed with a separate PC based software package - see “Event Viewing” section.

To install the DDC, remove the battery pack and push the DDC, label side up, into the thin slot in the side of the AED centered over the battery pack opening. The card should click into place and be flush with the surface of the slot. If the card does not push in all the way, it may have been inserted upside down. In that case, remove the card, flip it over and try inserting it again. To remove the DDC, press the card in all the way and then let go. The DDC will be partially ejected and can be removed by pulling it the rest of the way out.

3.3

Installing the Active Status Indicator 9V Battery

A user-replaceable lithium 9V battery, located inside the battery pack, provides Active Status Indicator (“ASI”) power. This auxiliary battery is used to provide standby indicator power independently of the main lithium battery (contained in the battery pack) allowing the main battery pack to have a significantly longer shelf and standby life. The unit will operate without a 9V battery installed in the battery pack, but active status indication will not be provided. If no 9V battery is installed, status can still be checked by turning the unit on. Only a fresh 9V lithium battery should be used as a replacement. Refer to the Maintenance section for more information on replacement batteries.



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The 9V battery is installed into the battery pack in the 9V battery compartment. To install, remove the cover covering the 9V battery compartment by pushing on it sideways. The cover will slide and detach from the battery pack. Insert the 9V battery into the 9V battery compartment so that the contacts on the battery touch the contacts in the battery pack. The orientation of the battery contacts is shown in a picture on the inside bottom of the 9V battery compartment. Replace the 9V battery compartment door by placing it in the almost closed position and then sliding it closed.