Digital Ultra User Manual Rev 05 June 2016

INDICATIONS FOR USE To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.

CONTRAINDICATIONS Contraindications for use of nitrous oxide/oxygen inhalation may include: 1. some chronic obstructive pulmonary diseases; 2. severe emotional disturbances or drug-related dependencies; 3. first trimester of pregnancy; 4. treatment with bleomycin sulfate; 5. methylenetetrahydrofolate reductase deficiency. 6. severe asthma Whenever possible, appropriate medical specialists should be consulted before administering analgesic/anxiolytic agents to patients with significant underlying medical conditions (e.g., severe obstructive pulmonary disease, congestive heart failure, sickle cell disease, acute oritis media, recent tympanic membrane graft, acute severe head injury.1 Operator must review patient history with regard to these health issues. 1

American Academy of Pediatric Dentistry. Clinical Guidelines: Guidelines on Use of Nitrous Oxide for Pediatric Dental Patients. Pediatr Dent 2009;31(6):148-151. Available at: “http://www.aapd.org/ media/policies.asp”. Accessed February 23, 2010.

WARNINGS To be used only by a professional trained in the use of nitrous oxide, using titration method. Patient should always be closely monitored during nitrous oxide use. If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed. The O2 flush button can be used to rapidly purge the lines of N2O. If patient does not show signs of quick recovery, remove nasal hood and treat with pure oxygen from either the O2 resuscitator fitting or an auxiliary oxygen tank using a demand valve, oxygen assisted manual resuscitator, or equivalent. Call for emergency assistance if rapid response is not achieved. Do not use this device for the administration of general anesthesia or as part of, or in conjunction with, a general anesthesia administration system. For use with 100-240 V AC, 50/60 Hz only. Use only hospital grade power cord connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.” For emergency power shut-off and isolation, unplug power cord from wall outlet. Unit is calibrated at the factory to ±5% per industry recommendations. Verify that the correct gases are being delivered to the correct flowmeter inlets by performing the oxygen failsafe test in section VII. NIOSH recommends N2O levels in operator area be kept below 25 PPM. Administer pure oxygen to patient for at least 5 minutes after nitrous oxide procedure.

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CAUTIONS

Federal (U.S.) law restricts this device to sale by or on order of a dentist or physician. Do not attempt to repair, alter, or calibrate this device. Unauthorized repair, alteration or misuse of this device is likely to adversely affect the performance and will void the warranty. Safety features contained in this notice should be routinely checked to assure proper function. If any of these safety features are not functioning properly, contact your dealer or Accutron and arrange for the necessary repairs before reusing the machine. Always use clean, dry medical gases. Introduction of moisture or other contaminants into Accutron analgesia gas machines may result in defective operation. Users of electronic flowmeters that control % oxygen should be aware that Accutron controls % nitrous oxide.

ELECTROMAGNETIC COMPATIBILITY (EMC) This equipment passes radiated emissions requirements for CISPR 11 Class B devices and EM field immunity requirements of IEC6100-4-3. Operating other radio frequency devices in the vicinity of this equipment should be evaluated accordingly. The minimum distance between this equipment and other RF devices is given by the formula below and the table. The minimum distance is determined by the power of the RF device operating in the vicinity of the digital flow meter. (Power)

minimum distance: d = ______ meters 0.388 Power

Distance (meters)

0.01 Watts

0.258

0.1 Watts

0.816

2 feet and 8 inches

1 Watts

2.58

8 feet and 6 inches

10 Watts

8.16

over 10 Watts

Distance (feet or inches) 10 inches

26 feet and 9 inches

Operating the digital flow meter within close proximity of such a transmitter is not recommended.

Warning: Changes or modifications to the equipment may result in unsafe operation. Recycling Old electrical and electronic equipment must be disposed separately and may not be included in the regular domestic waste. Dispose in accordance with prevailing ordinances. Alternatively, the unit can be handed over to Accutron for correct recycling. 3

Table of Contents

Page

Warnings and Cautions... 2

I.

Technical Specifications... 7

II.

Control/Display Features ... 8

III.

Digital Flowmeter Models

Flushmount... 10 Flexmount ... 12

Digital Newport... 14

IV.

Safety Features... 18

V.

General Instructions... 18

VI.

Directions for Use... 19

VII.

Periodic Equipment Checks... 23

VIII.

Troubleshooting Guide... 25

IX.

Warranty... 26

X.

Warranty & Returned Goods Policy... 27

XI.

Repair Service Policy... 27

XII.

Assistance... 27

XIII.

Ownership Information... 27

© 2016 Accutron, Inc. Part No. 26256 - Rev. 05 - 06/2016

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I. TECHNICAL SPECIFICATIONS Physical

Flushmount Main Unit 8x4x7.5” (20,3x10,2x19 cm) Weight: 5.2 lbs (2,4 kg) Flushmount Controller 9x4x1.5” (22,9x10,2x3,8 cm) Weight: 1.0 lbs (0,8 kg) Flexmount 8x4x7.5” (20,3x10,2x19 cm) Weight: 8.2 lbs (3,7 kg) Digital Newport 19x32x22” (48x80x56 cm) Weight: 75 lbs (34 kg)

Electrical

100-240 V AC 50/60 Hz. 0.5 A Socket is IEC/EN 60320-1 C14 and accepts an IEC/EN 60320-1 C13 connector Power cords available for most countries

Internal Battery

Lithium coin battery, 3v CR2032

Fuses

T500mAL, 250v (quantity 2) Accutron part number 26456-FRU

Gas Supply

Oxygen: 50-55 PSI at 100 LPM min. Nitrous Oxide: 50-55 PSI at 10 LPM min.

Gas Fittings

Oxygen Inlet: Male DISS CGA 1240 Nitrous Oxide Inlet: Male DISS CGA 1040 Mixed Gas Outlet: Male DISS CGA 1160 or 1/4” Hose Barb Oxygen Resuscitator Connection: 1/4” I.D. Quick Disconnect Adapter hoses available for AGA, DIN, NIST, BOC, AFNOR, SIS, UNIFO

Gas Delivery

Oxygen Flush: Minimum 20 LPM Oxygen Flow: 1.0 LPM-9.9 LPM (Accuracy +/- 0.5 LPM) Oxygen %: 30%-100% Oxygen Resuscitator Flow: Minimum 100 LPM, 100% O2 Nitrous Oxide Flow: 0-6.9 LPM (accuracy +/- 0.5 LPM) Nitrous Oxide %: 0-70% Mixed Gas Flow: 1.0-9.9 LPM

Environmental

Transportation/Storage: Temperature: -40°C to +70°C (-40°F to 158°F) Humidity: 10-100% Operating Conditions:

Temperature: 15°C to 32°C (68°F to 90°F) Humidity: 30-75% Atmospheric Pressure: 72-101 kPa (543-760 mmHg)

Accessories

Printer Remote Control Remote Flow System (RFS) Accu-Vac

Applied Part (rated BF)

Scavenging Circuit II Scavenging Circuit II (RFS) Scavenging Circuit II, ClearView Scavenging Circuit II, ClearView (RFS) 7

PN32007 PN32009 PN43003 PN43004

II. CONTROL/DISPLAY FEATURES Front Control/Display Panel % N2O Display

N2O Bar Display

O2 Bar Display

Total Flow Display

Information LEDs in this area

Increase Total Flow

Increase % N2O

Decrease Total Flow

Decrease % N2O

Cancel/Test Vacuum LED

Print

N2O Display

O2 Display

O2 Flush

Remote Control

Increase Total Flow

Increase % N2O

Decrease Total Flow

Decrease % N2O

Power (On/Off) O2 Flush

8

Power (On/Off)

Front Control/Display Panel & Remote Control Control/Display Panel – Easy-to-use control panel allows setting Total Flow and N2O concentration with the touch of a finger. Bright, color-coded displays make it simple to monitor status, even from a distance. Optional hand-held Remote allows functional control at patient chairside. Total Flow Control – Allows setting of Total Flow in either (.1) LPM or (.5) LPM increments. Once set, the Total Flow will remain constant even if % N2O is changed. Total Flow Display – Shows Total Flow in numeric LPM format with yellow LEDs. % N2 O Control – Allows setting of N2O concentration in either 1% or 5% increments up to a maximum of 70%. Once set, % N2O will remain constant even if Total Flow is adjusted. % N2 O Display – Shows % N2O in numeric format with blue LEDs. Power – Turns unit on and off with the push of a button. Flush Control – Ceases N2O Flow and provides a minimum of 20 LPM of pure O2 as long as button is pressed. O2 Flow – Two green LED displays show O 2 Flow in both LPM numbers and graphic bars simulating standard flow tube. N2 O Flow – Two blue LED displays show N2O Flow in both LPM numbers and graphic bars simulating standard flow tube. Print – When optional printer is installed, provides printout of current conditions. Cancel/Test – During an alarm mode, turns off audio alarm for one minute. During normal mode, performs self-check of all displays. Information LEDs – Informs administrator of failures with O2 supply, N2O supply, O2 flush, or mixed gas line to patient. Also indicates if remote vacuum is connected.

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III. FLOWMETER MODELS FLUSHMOUNT MODEL

Two piece design for easy installation into a cabinet or a wall. Thin control module located away from main module, power, and gas lines, requires remote outlet.

Flushmount Remote Outlets Options Sample Installation

a) Standard (Contains mixed gas outlet and O2 resuscitator connection)

b) Remote Flow System (RFS) (Contains mixed gas outlet, O2 resuscitator, and vacuum controller with gauge display) Green Light

MIN

MAX

VAC

MAX

O 2

c) Accu-Vac (Contains mixed gas outlet, O2 resuscitator, and vacuum controller with LED display) 10

Remote Control

Remote Vacuum 12 V DC Out

RS232 Printer

N2O Inlet DISS

O2 Inlet DISS

100-240 V AC Inlet IEC/EN 60320-1 C14 with two fuses. (Accepts IEC/EN 60320-1 C13 connector)

Mixed Gas Out (O2/N2O) – Connects to remote bag tee outlet

O2 Out – Connects to O2 Resuscitator fitting on remote outlet

Flushmount Main Module Utility Connections O2 Inlet – Labeled O2 IN – Equipped with male CGA 1240 DISS fitting to prevent gas mix-up. N2 O Inlet – Labeled N2O IN – Equipped with male CGA 1040 DISS fitting to prevent gas mix-up. O2 Out – Labeled O2 OUT – Equipped with male CGA 1240 DISS fitting, provides oxygen for resuscitator. Mixed Gas Port – Equipped with male CGA 1160 DISS fitting (Medical Air) Power Cord Inlet – Clearly labeled 100-240 V AC, 50/60 Hz and protected by two fuses for added safety. Fuses are 240 V, 0.5A, slow-blow. To disconnect power, unplug cord. Do not position where this disconnection would be difficult. RS232 Printer Connector – Clearly labeled and designed for use with optional Accutron-approved printer. Remote Control Connector – Remote Control connection. Using the Remote Control, general adjustments can be made from a distance of up to 10 feet away from device. Remote Vacuum Valve Connector – Clearly labeled and designed to actuate a vacuum valve in the Accu-Vac Automatic Vacuum Scavenging Port (PN 56955). O2 Out Connector – Direct connection to oxygen for use with resuscitator. Provides minimum of 100 LPM of oxygen. 11

FLEXMOUNT MODEL

Can be mounted on a number of different devices.

O2 Resuscitator Fitting Mixed Gas Port for Bag Tee

Flexmount Mounting Options

4-Cylinder Portable System

Mobile Stand

9” Wall Arm

Telescoping Wall Arm (Extends 12”-17”)

16” Bi-fold Wall Arm 12

Wall Arm and Mobile Stand version Remote Control

Remote Vacuum 12 V DC output

RS232 Printer

N2O Inlet DISS Note: Australian version has SIS fittings and slightly different layout.

O2 Inlet DISS

100-240 V AC Inlet IEC/EN 60320-1 C14 With 2 Fuses (Accepts IEC/EN 60320-1 C13 connector)

Mixed Gas Out (O2/N2O) – Connects to bag tee port on front of unit

O2 OUT – Connects to O2 Resuscitator fitting on front of unit

4 Cylinder version Remote Control

Remote Vacuum 12 V DC output

RS232 Printer

N2O Inlet DISS

O2 Inlet DISS

100-240 V AC Inlet IEC/EN 60320-1 C14 With 2 Fuses (Accepts IEC/EN 60320-1 C13 connector)

Mixed Gas Out (O2/N2O) – Connects to bag tee port on front of unit

13

O2 OUT – Connects to O2 Resuscitator fitting on front of unit

Flexmount Utility Connections O2 Inlet – Labeled O2 IN – Equipped with male CGA 1240 DISS fitting to prevent gas mix-up. N2 O Inlet – Labeled N2O IN – Equipped with male CGA 1040 DISS fitting to prevent gas mix-up. O2 Out – Labeled O2 OUT – Connects to oxygen resuscitator fitting on front. Mixed Gas Out – Connects to bag tee port on front. Power Cord Inlet – Clearly labeled 100-240 V AC, 50/60 Hz and protected by two fuses for added safety. Fuse ratings are 240 V, 0.5 A, slow-blow. To disconnect power, unplug cord. Do not position meter where this disconnection would be difficult. RS232 Printer Connector – Clearly labeled and designed for use with optional Accutron-approved printer. Remote Control Connector – Remote Control connection. Using the Remote Control, general adjustments can be made from a distance of up to 10 feet away from device. O2 Out Connector – Direct connection to oxygen resuscitator fitting on front. Provides minimum of 100 LPM of oxygen.

DIGITAL NEWPORT Handle Warning: Do not hold handle when opening cabinet.

10’ Hospital Grade Power Cord

Line Pressure Gauges

Regulators and E Yokes

Remote Control Port (Optional) O2 Resuscitator Fitting

Power Socket Note: Power Cord must be either unplugged from socket or unwound from storage cleats when opening Newport.

Removable Bag Tee

To disconnect power, unplug cord. Do not position where this would be difficult.

14

Tank Restraint Gas Cylinders If printer option is installed, printer cable will extend from cover at this point.

Digital Newport Setup and Connections View – When looking at the front of the Newport cabinet, Nitrous Oxide is on the left as shown by the blue Nitrous Oxide gauge. Oxygen is on the right as shown by the oxygen gauge. Opening Newport Cabinet – Open the Newport cabinet by placing one hand on the front cover and the other in the handle on the side. Pull handle back all the way. Make sure the power cord is unplugged from the socket in the skirt first. Install Gas Cylinders – 1. Undo Velcro straps 2. Angle tank into position 3. Strap tanks loosely 4. Remove regulators from accessories box 5. Attach regulators to tanks by loosening yoke handle, verifying seal is in place, aligning seal with gas opening, aligning pins with holes in yoke, tightening yoke onto cylinder NOTE: Regulators are pinned to match gas cylinders. Connect gas hoses to regulator outputs. NOTE: Hoses and regulators use DISS fittings to prevent mix up. Rotate cylinders so that regulators fit inside. Open Gas Cylinders – Pick one tank of each gas to be “in use“ tank and attach “in use” label to cylinder. Open these cylinders using the cylinder wrench provided in accessory box. Close Newport cabinet. Connect Power – 1. Plug cord back into skirt outlet 2. Plug other end of cord into receptacle NOTE: System will operate from 100-240 V, 50-60 Hz. Internal power supply will switch automatically. Scavenging Circuit – - Install bag tee from accessories box into front of Newport. - Attach scavenging circuit to bag tee. - Connect vacuum hose to system vacuum. - Install nasal hood into scavenging circuit and start vacuum flow per scavenging instructions. Start up – See Section VII , Directions For Use

15

Digital Newport: Managing Gas Supply Note: Power Cord must be either unplugged from socket or unwound from storage cleats when opening Newport. Identify the two in-use tanks (N2O and O2) by attaching “in-use” identification tags to them. 2. When one of the in-use tanks is empty, close the tank by turning the valve clockwise. Leave the empty tank in place. 3. Move the “in-use” tag to the appropriate reserve tank, which now becomes the in-use tank. Replace the empty tank with a new tank, which then becomes the reserve tank. 4. Open the valve of the new in-use tank by turning counterclockwise. Note: Do not open the reserve tank until the in-use tank is empty. When changing gas tanks, make certain both same gas cylinders that are involved in the exchange are closed. Always remember to switch the “in- use” tags over to the new tanks. 5. Contact gas supplier to request new gas cylinders as needed. 1.

Digital Newport: Changing Gas Cylinders Always use clean, dry medical grade gases. Introduction of moisture or other contaminants into Accutron Analgesia gas machines may result in defective operation. The Digital Newport Flowmeter System is designed to operate with a 50-55 psi line pressure on each gas (O2 and N2O). The line pressure can be determined by reading the O2 and the N2O line pressure gauges that are located on the front panel of the Newport. The Newport has features incorporated to make cylinder change-out easy. To assure proper operation of the system, 4 cylinders must be properly installed at all times. Please review the following cylinder replacement procedures before attempting to change cylinders. Note: Power Cord must be either unplugged from socket or unwound from storage cleats when opening Newport. 1. 2. 3. 4. 5. 6.

Open the tank enclosure by sliding the cover to the rear. Close the valve on the empty tank (clockwise). Release the Velcro restraint on the empty tank. Tilt the empty tank out slightly. Loosen the round handle on the regulator yoke. Remove the regulator from the empty tank (make certain that the regulator is not dropped or damaged while it is off the tank). 7. Lay the empty cylinder down on the floor (cylinders should only stand upright when properly restrained as they can easily fall over). 8. Pick up the full replacement tank and place the bottom of the tank onto the floor of the Newport, leaving it slightly tilted outward for easy replacement of the regulator. 9. Check to assure that the sealing gasket has remained on the regulator’s E yoke. 10. Reattach the regulator to the new full tank by sliding the yoke (attached to the regulator) over the top of the tank post aligning the index pins with the corresponding holes in the tank post. 11. Tighten the round handle on the regulator yoke. 12. Push the tank into an upright position. Attach and tighten the Velcro tank restraint.

16

Digital Newport: Control Module and Main Module Locations

Control Module is behind shield at front of unit.

Serial # Label

Main flowmeter module is behind shield at rear of unit. Fuses are located in fuse tray at power cord socket on back of flowmeter.

17

IV. SAFETY FEATURES O2 Fail Safe System – Offers assurance that N2O ceases if the O2 supply is interrupted or reduced. Alarm will sound, FAILURE OXYGEN LEDs will light, and N2O flow will cease. N2 O Supply Warning – Triggers an alarm if the N2O supply cannot keep up with user’s needs. Alarm will sound and FAILURE NITROUS LEDS will light. Flow switchs to 100% oxygen. Mixed Gas Flow to Patient – Monitors pressure in mixed gas line and triggers an alarm if flow to patient is obstructed. Alarm will sound and FAILURE NITROUS OXYGEN LEDS will light. Emergency Air Valve – Automatically provides patient with ambient air if gas flow is interrupted. Located on remote bag tee. Directional Check Valve – Prevents re-breathing of exhaled gases and protects against CO2 buildup. Located on remote bag tee. O2 Resuscitator Connection – Direct connection to O2 for use with resuscitator. Port is always open and provides 100 LPM minimum of pure oxygen.

V. GENERAL INSTRUCTIONS 1. Warranty Unpack Digital Ultra and inspect to make certain that the unit has not been damaged during shipment. The unit’s serial number is located on the back of Digital Ultra (see page 17 for Digital Newport’s serial number location). Record the serial number in the area provided at the back of this booklet. Once Digital Ultra Flushmount is mounted into a cabinet, the serial number will no longer be visible. Always reference the serial number when corresponding with Accutron. Complete the warranty card supplied with Digital Ultra and mail to Accutron. Completion of this step ensures proper device warranty coverage. Accutron Digital Ultra analgesia machines carry a two-year limited warranty (see Warranty on page 26 for details).

2. Gas Supply Connection Always use clean, dry medical gases. Introduction of moisture or other contaminants into Accutron analgesia gas machines may result in defective operation. After device installation, connect the oxygen and nitrous oxide supply lines to the Diameter Specific Instant fittings or DISS fittings located on the back of the device. See pages 14-16 for information specific to the Digital Newport. It is important that the regulators for both gases be set to give pressures in the range of 50-55 PSI. Verify that the correct gases are being delivered to the correct ports on device before initial use. This can be done by shutting off the O2 cylinders and turning the unit on. The unit should immediately go into an oxygen failure fault mode. If unit indicates O2 gas is flowing, lines are crossed. Correct before using. 18

3. Power Connection Device is designed to run on 100-240 V AC and 50/60 Hz. There is no need to flip an external switch; the unit automatically adjusts for any power. A medical-grade power cord is supplied with the unit and must be used to ensure proper grounding. It is important that the power cord be plugged into an outlet marked “Hospital Only” or “Hospital Grade.” The power cord is plugged into the AC entry, which contains two fuses and is located on the back of the device. International power cords are offered for most countries. Use only 240 V, 0.5A, slow-blow fuses. Fuses can be ordered from Accutron as part number 26456-FRU.

4. Auxiliary Connections Plug remote control into remote port on back of Digital Ultra or on front cover of Newport if ordered as option. Plug Accu-Vac signal line into vacuum connector on back of Digital Ultra (Flushmount only). Vacuum LED should light when Digital Ultra is powered indicating vacuum is flowing. Plug printer cable from Able printer, if used, into RS232 printer port. Do not use this port for any other devices. If printer is ordered on Newport as option, printer cable will extend from front cover. Note: Use only Able printer supplied by Accutron.

VI. Directions For Use Read instructions completely before operating Digital Ultra device. Note: The steps listed below provide a basic functional description of the Digital Ultra usage. A training course that emphasizes a practical, hands-on approach combined with instructions on safe techniques for administration of nitrous oxide-oxygen conscious sedation is recommended before use of this flowmeter. Do not use this device for the administration of general anesthesia or as part of, or in conjunction with, a general anesthesia administration system. Unit must be connected to O2 and N2O gases at 50-55 PSI. Unit must be plugged into 100-240 V AC, 50/60 Hz power outlet. Use titration method for administering nitrous oxide. Power button will shut off Digital Ultra normal functions (reference diagram on page 8). For Emergency shutoff, unplug power cord. NOTE: Detailed information on users, patients, and conditions can be found at the end of section VI.

General Operating Instructions

Setup: Verify the presence of separate means of oxygen resuscitation and that appropriate staff are trained in its operation. WARNING: In cases of adverse reactions, discontinue nitrous oxide procedure, remove scavenging circuit, utilize auxiliary resuscitation measures and equipment, and contact Emergency Responders (911). Verify that oxygen and nitrous gases have not been mixed up by performing the Oxygen Failsafe Test on page 23. Note: the only significant source of injury from nitrous oxide procedures is gas mix-up. Open inlet gas supplies for oxygen and nitrous oxide by: a. Turning on manifolds in central systems or b. Opening gas cylinders in Newports and 4 cylinder mobile stands Verify scavenging vacuum is turned on and properly set per scavenging circuit Instruction for Use Verify power to flowmeter 19

Operation: 1) Push POWER button on front membrane or on Remote Controller. (Initial flow is set to 5.0 lpm at factory but can be adjusted per instructions on page 21) 2) Install scavenging circuit per scavenging circuit Instructions for Use. 3) Adjust proper breathing flow by using the TOTAL FLOW and TOTAL FLOW buttons. Reservoir bag should inflate and deflate in response to patient breathing but never go completely full or completely empty. (Increments are set at factory to 0.5 lpm but can be reset to 0.1 lpm increments per instructions on page 20). 4) Gradually add nitrous oxide by using the % N2O. It is recommended that % start at 10% and be increased by 10% intervals until desired reaction is achieved. Allow time between each change for patient to adjust since rapid increasing of N2O % can cause nausea. (Increments are set at factory to 5% but can be adjusted to 1% per instructions below) Note: Total flow does not change if % N2O changes and % N2O does not change if Total Flow changes. Caution! Accutron controls % N2O. Refer to page 22 for possible Use Error for those who are used to meters that control % O2. 5) Max % N2O is set at the factory to 70%. This limit can be changed to 50% by following instructions on page 21. 6) Adjust Total Flow and % N2O as needed to maintain proper anxiety relief and proper flow levels. 7) Turn % N2O to 0 at the end of the procedure by using the % N2O. Continue with pure oxygen for 5 minutes. 8) Stop gas flow by pushing POWER at the end of the procedure. Remove scavenging circuit and close vacuum. Additional Functions: Print - If a Printer is installed, a snap shot of current O2 flow, N2O flow, Total Flow, % N2O, Time and Date can be printed by pushing PRINT. Mute - During an alarm condition, sound is muted by pushing CANCEL/TEST Led Test - During normal operation, CANCEL/TEST will cycle though all Leds to verify all are operational Flush - A minimum 20 lpm of pure oxygen will flow when FLUSH is pushed

Setting Step Size of Total Flow and % N2O 1.

To set the % N2O step size to 5%: Plug in Digital Ultra and leave off. Press and hold % N2O Up (+) button until beeps (approx. 5 seconds). 2. To set the % N2O step size to 1%: Plug in Digital Ultra and leave off. Press and hold % N2O Down (-) button until beeps (approx. 5 seconds). 3. To set Total Flow step size to 0.5 LPM increments: Plug in and turn off Digital Ultra. Press and hold Total Flow Up (+) button until beeps (approx. 5 seconds). 4. To set Total Flow step size to 0.1 LPM increments: Plug in and turn off Digital Ultra. Press and hold Total Flow Down (-) button until beeps (approx. 5 seconds).

Setting Date and Time 1. 2. 3. 4.

Plug in Digital Ultra and leave off. Press and hold Print button down until beeps (approx. 5 seconds). This will start year setting. Display will show 20 in % N2O box and flashing display in Total Flow box. Adjust to current year using Total Flow Up/Down buttons. Push % N2O Up (+) button to store value and proceed to next step.

20

5. 6. 7. 8.

% N2O box now displays months. Set the month with Total Flow Up/Down buttons. Push % N2O Up (+) button to store value and proceed to next step. Total Flow box now displays days. Set the day with Total Flow Up/Down buttons. Push % N2O Up (+) button to store value and proceed to next step. N2O box now displays the hours. Set the hour with Total Flow Up/Down buttons. Push % N2O Up (+) button to store value and proceed to next step. N2O box now displays minutes. Set the minute with Total Flow Up/Down buttons. Push the cancel button to save value and exit program.

Changing Starting Total Flow Rate With power connected and flowmeter off, press and hold CANCEL/TEST and Total Flow + (up) Arrow together until beep (5-7 seconds). Current Total Flow will be shown. Adjust to desired flow rate using Total Flow + Up and Total Flow Down buttons. Acceptable values are 1.0 to 9.9 LPM. Press Flush button to accept new value. Starting Total Flow will now start at the new value.

Changing Max N2O Percentage (50% 70%) With power connected and flowmeter off, press and hold CANCEL/TEST and N2O % Up + buttons together until beep (5-7 seconds). This will toggle between 50% and 70%.

Changing Operating Mode (Normal/Demo) With power connected and flowmeter off, press and hold CANCEL/TEST and O2 FLUSH buttons together until beep (5-7 seconds). This toggles between Normal (gas flow) mode and DEMO (no gas flow). When in Demo mode, unit will start up flashing SALES for 5 seconds. In this mode, controls and displays will act normal but no gas will be needed or allowed to flow.

Set to Constant 50/50 Mode This is done at the factory via an internal switch. In 50/50 mode, unit will supply a constant 50% Nitrous Oxide/50% Oxygen mix. Total Flow can be adjusted but will remain 50/50. As a safety feature, the unit can be toggled back and forth between 50/50 and 100% oxygen by using the Nitrous % Up and Down Arrows. 50/50 mode is often used in ERs to minimize shock and in Obstetrics for labor pains.

Application Specifications Intended Use The Accutron Digital Flowmeter is used to reduce anxiety in dental patients so that traditional treatments can be performed more efficiently and with less stress on the patient.

Intended Medical Indication Nitrous oxide in Accutron approved applications is used for anxiety relief and is not a treatment for any particular medical indication per se. It is used to calm patients so that other treatments may be performed. It is proscribed for conscious sedation only and not for use with other anesthesia agents.

Intended patient population Nitrous oxide is routinely given to healthy individuals over 2 years of age without distinction of age, sex, or weight. See pages 2 and 3 for contra-indications. NOTE: Patient reaction to nitrous oxide can vary widely between individuals and even in same individuals over time. Some individuals can not tolerate any N2O. 21

Intended part of the body Nitrous oxide is a gas and is delivered to the nose via a nasal hood connected to gas supply tubing. The patient inhales the gas which is then absorbed in the lungs.

Intended user profile Medical professionals such as doctors, dentists, dental assistants, dental hygienists, and nurses who have been formally trained in the use of nitrous oxide and who have studied the operating instructions in the User Manual.

Intended conditions of use The Accutron Digital flowmeter is intended to be used in medical facilities such as dental offices and hospitals with standard controlled room environments. See section I for further environmental specifications. Units may be mounted in cabinets, on extension arms, on sliding brackets, or on mobile carts. Units are not meant to be hand mobile by personnel and are not meant to be used in emergency vehicles. Frequency of use can vary from rare (once a month) to (frequent) 10-15 times per day. The user interface is designed for asepsis cleaning.

Description and operating principle The Accutron Digital PC Flowmeter is a microprocessor-controlled device that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes in Dental Offices and Hospitals. The flowmeter is powered by 100-240 VAC, 50/60Hz via a power cord that is plugged into a filtered inlet. This voltage is then automatically converted to 24 VDC by a switching medical grade power supply. All components within the flowmeter as well as the user interface are operated on 24 VDC or less. Precise flow of both oxygen and nitrous oxide are achieved through a feedback circuit containing a proportioning solenoid, a medical grade mass flow sensor, and the main microprocessor. The mass flow sensors measure flow electronically giving real time updates to the circuit board which directs the solenoids to maintain desired flow rates. The processor monitors these flows and gives alarms as needed if the flow of either gas can not match the desired rates. The software also prevents nitrous oxide from flowing without oxygen and maintains oxygen levels at 30% or more at all times. Clinical operation is very simple as there are only two items to control, TOTAL FLOW and %N2O. Press POWER to start flow which comes on at 5.0 LPM Total Flow and 0 %N2O. Adjust Total Flow with the + and – keys until it matches the patients breathing rate. Increase % N2O by using the + and – keys until proper relaxation is achieved. Decrease % N2O to 0 at end of procedure and continue with pure oxygen for 5 minutes. Turn Power off. Total Flow and %N2O can be adjusted during procedure as needed. Pure oxygen flush is available at any time. Print option is also available. Possible Use Errors • Administering too much N2O or increasing the %N2O too quickly • Mistaking the %N2O with %O2 used by other electronic flowmeters • Not taking sufficient patient history before starting procedure • Not reading the instructions for use or undergoing nitrous oxide training prior to starting procedure

22