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PARAMEDIC CU-ER3

Paramedic CU-ER3 - this defibrillator has the capabilities of the Paramedic CU-ER2 plus SPO2 monitoring capability. SPO2 indicates the amount of oxygen saturation in the blood. It is intended for use by emergency first responders. With its ECG and SPO2 monitoring capabilities, it may also be used in hospitals when a low cost defibrillation and monitoring capability is desired.

Dual Mode Defibrillator

The Paramedic CU-ER3 is a portable external defibrillator with the following modes:

Automated External Defibrillation (AED) Mode

Manual Mode

In AED Mode, the Paramedic CU-ER3 analyzes the ECG of the patient to determine whether the patient has a shockable or nonshockable ECG rhythm. In this mode, the Paramedic CU-ER3 provides you with voice and text prompts throughout a rescue operation.

In Manual Mode, the Paramedic CU-ER3 lets you control the defibrillation process. You assess the ECG of the patient and set the energy of the shock to be delivered. You may also perform synchronous cardioversion for the treatment of atrial fibrillation in this mode. In synchronous cardioversion, the defibrillating shock is delivered within 60 milliseconds of the occurrence of a QRS peak in the patient’s ECG.

SpO2 pulse oximetry with alarm

The Paramedic CU-ER3 is capable of monitoring pulse oximetry (SPO2) in manual and AED modes. Pulse oximetry measurement is automatically done when the pulse oximetry sensor is connected to the appropriate port of the device.

ECG monitoring (3 Lead ECG cable)

The Paramedic CU-ER3 may also be used to do ECG monitoring only when it is in Manual mode. ECG monitoring only is done by connecting the custom designed ECG monitoring cable assembly from CU Medical Systems, Inc. No shocks may be delivered when the ECG monitoring cable assembly is connected to the Paramedic CU-ER3.

Intelligent Data Management System

The Paramedic CU-ER3 automatically records ECG and events such as shock deliveries in nonvolatile memory during rescue operations. These data may be printed directly using a portable printer or downloaded to a personal computer for printing and archiving.

Versatile Power Supply

The Paramedic CU-ER3 is powered by an internal rechargeable Nickel Metal Hydride battery pack. It may also be powered by an optional external disposable LiMnO2 battery pack or its AC/DC adapter. While the internal battery is being recharged by the AC/DC adapter, the AC/DC adapter also supplies power to the whole device which enables it to be fully functional.

Automatic and operator initiated Self-Test

The Paramedic CU-ER3 is easy to troubleshoot and maintain. It is programmed to conduct automatic Power On, Run Time, Daily, Weekly, and Monthly self tests. During these tests, the critical subsystems of the device are tested for functionality. If a fault is detected, the device informs you of the fault through audible and visible indicators.

- Manual and AED Operation

- Synchronized cardioversion

- Efficient and effective e-cube Biphasic technology (BTE Type)

- SpO2 pulse oximetry with alarm

- ECG monitoring (3 Lead ECG cable)

- CPR coaching

- Lightweight (about 2.8kg) and highly portable

- Versatile power supply

a.Rechargeable battery pack / Disposable battery pack

b.AC/DC adapter

c.Car cigar lighter jack

- Intelligent data management system

a.Internal flash memory : 12 hours of event and ECG recording

b.SmartMedia card (32M) : 42 hours of event and ECG recording or 1 hour voice recording

- External Link : UART port / IrDA port

- Automatic and operator initiated Self-Test (Power on / Run time / Daily / Weekly / Monthly)

Physical

Size	305 mm X 250 mm X 95 mm (L X W X H)
Weight	Approximately 2.8 kg

Environmental

Operating Conditions	Temperature	32 °F to 104 °F (0 °C to 40 °C)
	Humidity	5 % to 95 % (non-condensing)
Standby Conditions (Ready for rescue, stored together with defibrillator electrode pads)	Temperature	32 °F to 109 °F (0 °C to 43 °C)
	Humidity	5 % to 95 % (non-condensing)
Storage Conditions (device only, no defibrillator electrode pads)	Temperature	-4 °F to 140 °F (-20 °C to 60 °C)
	Humidity	5 % to 95 % (non-condensing)
Shock/Drop/Abuse Tolerance		Meets IEC 60601-1 clause 21 (Mechanical Strength)
Vibration		Meets MIL-STD-810E Method 514.4 Category 10
Sealing		Meets IEC 60601-1 clause 44 (Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, and disinfection)
ESD		Meets IEC 61000-4-2:2001
EMI (Radiated)		Meets IEC 60601-1-2 limits, method EN 55011:1998+ A1:1999 +A2:2002, Group 1, Class B
EMI (Immunity)		Meets IEC 60601-1-2 limits, method EN 61000-4-3: 2001 Level 3 (10V/m 80MHz to 2500MHz)

Defibrillator

Operating Modes

Manual / Semi automatic

Waveform (Manual and AED Modes)

e-cube biphasic (Truncated exponential type); impedance compensated

Shock Delivery

Via multi-function defibrillator electrode pads

Patient Impedance Range (Manual and AED Modes)

25Ω to 175Ω

Manual Mode

Output Energy (Delivered)

2, 3, 5, 7, 10, 20, 30, 50, 70, 100, 150, 200 Joules

Controls

Power ON/OFF, SHOCK, Mode/Energy Choose, CHARGE, DISARM, SYNC, , Plethysmographic wave display ON/OFF, Monitor Alarm Menu, Alarm Silence

Indicators

Electroluminescent back lit Liquid Crystal Display for ECG waveform and Plethysmographic wave, text prompts, Alarm indicators, and Menu Operation Display

Armed Indicators

“Charging complete” text prompt

Continuous tone on beeper

Flashing red backlight of the SHOCK button

Energy Choice

Mode/Energy Knob

Charge Control

ANALYZE/CHARGE Button

Shock Control

SHOCK button

Synchronizer

SYNC message appears on the LCD

Audible beep when R-wave is detected

Tick mark R-wave marker on the LCD screen

Shock is delivered within 60 ms of an R-wave occurrence

AED Mode
AED Energy Profile	Fixed energy at 150 Joules
Text and Voice Prompts	Provided to user in every step of a rescue operation
AED Controls	Power On/Off, Pause/Disarm, Analyze/Stop Analysis, Pause/Resume, SHOCK, Volume control
Indicators	Electroluminescent back lit Liquid Crystal Display for ECG waveform and Plethysmographic wave, text prompts, and Alarm indicators.
Armed Indicators	“Charging complete” text prompt Continuous tone on beeper Flashing red backlight of the SHOCK button
Patient Analysis	Detects and evaluates connection impedance for proper defibrillator electrode pads contact. Analyzes patient’s ECG to determine if a shock is necessary.
Shockable rhythms	Ventricular fibrillation and ventricular tachycardia with rates > 150 bpm
Sensitivity and Specificity	Meets AAMI guidelines
ECG Monitoring Mode
Inputs		Single channel ECG may be viewed on LCD and printed. Lead II ECG is acquired using a 3-wire ECG cable and connector assembly
Lead Fault		“CHECK PADS” prompt and dashed line on BPM value are displayed when the ECG cable and connector assembly is disconnected from the ECG-DEFIB port.
Heart Rate Display		Digital readout display from 30 to 300 bpm with an accuracy of ±2 %
Heart Rate Alarm		You may set the lower and upper limits with the following values: Lower limit: from 30 to 299 bpm Upper limit: from 31 to 300 bpm
ECG Cable Length		3 meters
Common mode rejection		Greater than 90 dB measured per AAMI EC 13
ECG size		5 mm/mV 10 mm/mV 20 mm/mV AUTO : 0.3 to 1 mV signals are displayed with 10mm/mV gain, outside of that range, the peak to peak value is displayed as 10 mm on the LCD display)
Frequency Response		ECG Monitoring Mode: 0.3 to 40 Hz (-3 dB) AED and MANUAL modes (EMS): 1 Hz to 30 Hz
Patient Isolation (Defibrillation Proof)		BF for all modes
SPO2 Pulse Oximetry
Displayed Pulse Rate		20 to 250 bpm (±3 bpm)
Displayed Saturation (SPO2 value)		70 to 100% (±3%)
Perfusion		0.2%
SPO2 Alarm Limits		Lower limit: 85% to 1% less than the upper limit Upper limit: 100% to 1% more than the lower limit
Display Update Interval		6 seconds
Resolution		1 %
Nellcor Sensors
DS100A Sensor
Wavelength		Near 660 nm and 890 nm
Power		Not exceeding 15 mW
Event Storage
Internal Flash Memory		12 hours of event and ECG recording
SmartMedia Card (32MB):		42 hours of event and ECG recording or 1 hour if voice recording is enabled
ECG Record Printing		May be printed directly from the Paramedic CU-ER3 using a portable thermal printer. May also be printed using a personal computer by downloading the data to the PC using the data management software from CU Medical Systems, Inc. (CU Expert)
External Links
UART Port
IrDA Port
Display
Type		Liquid Crystal Display with electroluminescent backlight
Size		4 inches (10.16 cm) diagonal
Resolution		320X240 pixels
Sweep speed		25 mm/s nominal, stationary trace, sweeping erase bar
Viewing Time		3.2 seconds
Battery
Internal Battery Pack
Type		4500mAh, 12V, rechargeable, Nickel Metal Hydride
Dimensions		89mmX36mmX69mm (LXWXH)
Weight		About 620grams
Charge time		4 to 5 hours
Capacity		200 shocks at 150 Joules
Battery Indicators		Battery level indicator Battery charging indicator
Battery Storage		Should not be stored beyond 40 °C for extended periods (more than 90 days)
Charger output		Unit can be used while the internal battery is being recharged
External Battery Pack
Type		4200mAh, 12V, Non rechargeable, LiMnO2,
Dimensions		104mm X 67mm X 42mm (LXWXH)
Weight		Approximately 423 grams including connector
Capacity		200 shocks at 150 Joules
Battery Indicators		Battery level indicator
Battery Operating Temperature		-40 °C to 60 °C

	Standard Package
	- Device - Disposable Defi pads - Power cord - AC adapter - NI-MH battery - SpO2 Probe (Nellcor) - User’s guide - Quick reference card

	Optional Accessories
	- Carrying case - SMC (32M) - External memory card - Printer (RS232C) - Printer Paper (10 rolls) - Cigar lighter jack for car - ECG cable (3 Leads) - ECG Electrodes (50EA) - Disposable Battery Pack (Li-ion) - Software for data managing with Key File (UART Cable Included) - Pediatric Pads (CU)