Precision Flow Operating Instruction Manual Rev E

Table of Contents Section 1

Page

Symbols

3

Indications, Warnings and Cautions

4

Section 2

Overview

6

Section 3

Principles of operation

7

Section 4

Controls, displays & connections

8

Section 5

Modes of operation

11

Section 6

Initial assembly

12

Section 7

Setting up

13

Section 8

Adjustments

17

Section 9

Connecting to patient

17

Section 10

Operating guidelines

18

Section 11

Inserting & changing the disposable patient circuit

19

Section 12

Alarms

20

Section 13

Shut down

23

Section 14

Routine maintenance

23

Section 15

Cleaning and disinfection

24

Section 16

Specifications

25

Appendix: Audio Tone Characteristics Software modes EMC Guidance

27 28 29

Symbols

0297

Vapotherm Inc. has declared that this product conforms with the European Council Directive 93/42/EEC Medical Device Directive when it is used in accordance with the instructions provided in the Operation Manual.

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as an unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Precision FlowTM Packaging contains: Precision Flow Unit Operating Instruction Manual Power Cord O2 Sensor cell Air & Oxygen Inlet Particulate Traps with Connectors US ONLY- Air and Oxygen Hoses

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For further information contact:

Authorized Representative:

Vapotherm Inc. 198 Log Canoe Circle Stevensville, MD 21666 USA.

RMS – UK Limited 28 Trinity Road Nailsea, Somerset BS484NV England

Phone: 410-604-3977 Fax: 410-604-3978 www.vtherm.com

Phone: +44-1275-85-88-91 Fax: +44-1275-85-88-91

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Section 1 Indications, Warnings and Cautions

Section 1 Indications, Warnings and Cautions

General Indications & Contraindications. Primary Indications:

Make sure all Disposable Patient Circuit connections have been properly secured.

Used to warm and humidify breathing gases, generally prescribed during oxygen therapy where concentrations of oxygen greater than ambient air are utilized to treat symptoms and manifestations of hypoxia. Contraindications: General: Any situations in which humidification is contra-indicated (see AARC Clinical Practice Guidelines).

The cartridge, disposable water path and delivery tube are labeled as single patient use only and must be replaced after 30 days use on a single patient: do not attempt to sterilize or reuse and follow all local and federal regulations for disposal. Outside the USA follow national or international regulations. Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial contamination. • The Precision Flow™ utilizes warmed water and can pose a risk for colonization of bacteria and patient infection if proper aseptic technique is not followed. • Gas supply is external to the Precision Flow,™ but the care giver should confirm the integrity of all respiratory gases utilized to ensure they are free of contamination. Gas supply must be made of clean dry medical grade gas to prevent harm to the patient and prevent damage to the Precision Flow.™

Specific to Nasal Cannula: Patients with occluded or defective nares should not use the system.

Warnings and Cautions A Warning indicates that a situation may occur which is potentially harmful to the patient or user. A Caution indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation. A Note indicates a point of emphasis to make operation more efficient or convenient.

The Precision Flow™ is not a Continuous Positive Airway Pressure (CPAP) device. There are no controls to deliver or monitor airway pressure. The Precision Flow™ should not be used to deliver pressure in a closed system.

Please take the time to familiarize yourself with the warnings, cautions, and notes listed in this manual. They cover safety considerations, special requirements, and regulations.

Never connect the unit to a patient until it reaches set point temperature (temperature display stops flashing). Allow the unit to warm-up to purge condensate and prevent patient discomfort due to cold or partly humidified gas. Additional patient monitoring is necessary if the Precision Flow™ is used to give supplementary oxygen. The Precision Flow™ is not MRI compatible.

The user of this product shall have sole responsibility for any malfunction due to operation or maintenance performed by anyone not trained by Vapotherm staff or official training documentation. When handling any part of the Precision Flow,™ always follow hospital infection control guidelines and Standard Precautions. Vapotherm also recommends that users follow the Centers for Disease Control (CDC) publications: Guidelines for Maintenance of In-Use Respiratory Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia. General Warnings Federal Law (U.S.) restricts the sale of this device to, or by the order of any physician. This device should be used ONLY by a trained operator. This is a humidification device generally used for providing continuous flows of breathing gas. The Precision Flow™ is not a ventilatory device and should not be used as life support. Oxygen supports combustion; this device should not be used near or around open flames, oil, or grease, or flammables.

The unit is provided with a Hospital Grade power cord. Do not use any other cord. Do not use extension cords. For grounding reliability, the cord must be connected to an equivalent receptacle marked “Hospital Grade” or “Hospital Only”. If any doubt exists as to the grounding connection, do not operate the device. Medical electrical equipment needs special precautions regarding electromagnetic radiation. Portable and mobile RF communications equipment can affect medical equipment and should not be used near the Precision Flow™ . General Cautions Read and understand this manual prior to operating the system. Clamp water supply when not in use to prevent equipment damage by water ingress.

Service on the device should only be performed by qualified, certified service technicians.

Aseptic techniques (including hand washing and avoiding hand contact with connection points) and Standard Precautions should always be followed when handling medical equipment. Standard Precautions should always be followed when coming into contact with patients.

To prevent injury, do not attempt to do any service to the Precision Flow™ while a patient is connected to the device.

Do not cover the unit; blocking the vent may damage the unit. Do not:

If the device is damaged or not working properly, do not use. Contact Vapotherm or your authorized Vapotherm representative. Do not operate if power cord is damaged. The device should not be turned on and left unattended. Do not use the Precision Flow™ in or around water, other than the water bag that feeds the system.

• immerse the Precision Flow™ in water. • steam or gas sterilize the Precision Flow.™ • wipe with bleach. Flexible sterile water bags are recommended. If rigid or semi-rigid bottles are used, an approved venting bottle cap must be used.

Prior to use, the Precision Flow™ should be positioned and secured to a sturdy IV pole with the base of the unit no more than 40” (102cm) above the floor.

NOTE: The Precision Flow™ may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). However, for the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be 40 psi (276 kPa) or above.

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Section 2 Overview

Section 3 Principals of operation

The Precision Flow™ is a system for high flow humidified respiratory therapy by nasal cannula. It incorporates the Vapotherm core humidification technology with an electronic blender and flow controller. The water and gas pathways are both incorporated into a removable, disposable patient circuit. The only cleaning and disinfection required is wiping the housing with an approved disinfectant wipe after use.

The Precision Flow™ warms and humidifies a flow of breathing gas for delivery by nasal cannula at flows from 1 to 40 lpm. The unit incorporates an electronic blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently.

Features

• No disinfection necessary: the patient circuit is detachable and disposable • Minimal downtime between patients: less than five minutes to change disposables • Built-in oxygen blender • Built-in electronic flowmeters and controllers • Self-testing and self-calibrating • Internal battery backup maintains flow and oxygen percentage for at least 15 minutes if AC power is cut off. Battery recharges in 2 hrs. • All internal sensors self-calibrating and self-monitoring • Single button starts and stops the device • Temperature, flow and oxygen percentage are adjusted via a single setting control knob on the front panel • All values and alarms displayed in a single large color-coded panel • Flow range 1-40 lpm • Oxygen percentage is fully adjustable from 21to 100% when two 40 psi (276 kPa) gas sources are used

Precision Flow™

• Inlet gas pressure range is 4-70 psi (28-482 kPa) • Single gas operation- the precision FlowTM detects inlet gas pressure and blends flow based on demand required and available supply. Supply pressure determines FiO2 and delivered flow; if demand exceeds supply an alarm sounds • At low gas inlet pressures, maximum flow rate and oxygen percentage settings are automatically reduced to match the inlet pressure • Automatically senses cartridge type: maximum flow setting is automatically reduced if low-flow cartridge is installed • Warm-up time less than five minutes • Sterile water is connected to the disposable water path using a standard spike • Easy connection between the delivery tube and disposable water path by a simple press and click fitting • Universal power requirements allow use anywhere with only a change of power cord • Scheduled maintenance for internal components at 3 year intervals, external gas filters replaced at 6-month intervals, external oxygen sensor replaced annually Page 6

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The Precision Flow™ consists of two parts: Main unit • The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers, and remote sensors to monitor the disposable water path. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. • The flow of oxygen and air are measured by mass flow sensors. The operating software calculates the required flow of each needed to reach the target flow and oxygen percentage set by the operator. The system controls gas flows accordingly by adjusting proportional solenoid valves on the gas lines. An oxygen sensor monitors the gas mixture and signals any discrepancy between target and measured percentage. The oxygen sensor is automatically calibrated with oxygen at power-up and every 24 hours. • Firmware running in the main unit uses sensors to monitor gas pressure, water level and water temperature, and to detect air leaks into the water circuit (bubble detector) and water leaks into the gas circuit (droplet detector). Alarms are displayed if any parameters are outside the normal range. Other indicators show low charge in the backup battery, and the type of cartridge installed. See Appendix for a description of the firmware states and transitions. • An internal battery backup will maintain the set flow and oxygen blend for at least 15 minutes without AC power. The battery is not operator replaceable. Disposable patient circuit • The disposable patient circuit is comprised of the disposable water path, vapor transfercartridge and delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable water path. • Vapor transfer cartridge. In the cartridge blended gas passes through the lumens of hundreds of parallel hollow fibers made of a specially developed polymer. Warm water circulates around the fibers and diffuses as vapor through the fiber material into the gas stream flowing through each fiber. Unlike most humidifiers, there is no direct contact between the water and gas streams. The gas stream leaves the cartridge essentially saturated with vapor at the set temperature. Note: Use only approved cartridges from Vapotherm Inc. • Patient delivery tube. The warmed humidified gas passes through the center of a triple-lumen heated delivery tube. The center lumen is surrounded by two outer lumens carrying warmed water to maintain the temperature of the inner lumen and to minimize rain-out. A proprietary short nasal cannula is connected to the end of the delivery tube and passes the humidified breathing gas to the patient’s nares. • Disposable water path. The disposable water path houses a water reservoir, pump, connections for the cartridge and delivery tube, and sensor interfaces to the main unit. Water is pumped past a heater plate through the outer lumens of the delivery tube. Returning water passes through the outer jacket of the specially designed vapor transfer cartridge where some water is lost as vapor to the gas stream. There is no direct contact between water and gas flows. The water then returns to the pump reservoir. Heater power is adjusted continuously to maintain the set temperature. Water flows into the circuit from the water bag to replace evaporative losses in the vapor transfer cartridge. Air is purged to atmosphere from the circulation via a hydrophobic filter membrane. See Section 5 for a description of the modes of operation. 6/10/2008

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Section 4 Controls, displays & connections

Section 4 Controls, displays & connections Front view 1

1

1. Folding carrying handle 2

2 3

13 3 12

11 4

4

2. Multi-function display: • Shows set values for oxygen %, flow and temperature • Icons indicate alarm conditions 3. Alarm mute: • Press to silence alarms for up to 2 minutes • LED indicates one or more alarms are muted 4. Setting control knob: • Press to select which variable to adjust • Rotate to adjust to new value • Press again to set value

5

10

6 7

9 8

5

1. Battery low or charging 2. Disposable water path faulty or absent 3. Vapor transfer cartridge type 4. Vapor transfer cartridge fault 5. Gas supply fault 6. Status LED 7. Run/Standby button (see note)

8. Setting control knob 9. Alarm mute button 10. Alarm muted LED 11. General fault 12. Water low/water out 13. Blocked tube

5. Sliding door: • Slides forward to install or remove disposable water path 6. Status light: • Amber in standby • Flashing green when output does not match settings (e.g. during warmup) • Steady green when unit is operating normally 7. Run/standby button: • Press to start unit after water and gas are connected

6

7

Note: The Precision FlowTM has no ON/OFF switch. Plug the unit into a wall outlet to keep the battery fully charged. Page 8

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Section 4 Controls, displays & connections

Section 4 Controls, displays & connections

Docking station for disposable water path 1

WARNING: Heater plate may be hot!

2

3

4

5

6

7

8

Arrows show location of optical sensor ports. Do not scratch or scrub the ports. Do not apply organic solvents or bleach.

Rear view 1. Sliding door • Slide forward to install or remove disposable water path 2. Oxygen bleed vent 3. Access panel for oxygen sensor (see note) 4. Pole clamp 5. Power cord connection and fuse holder 6. DISS oxygen connection 7. DISS air connection 8. Gas inlet filters and traps Note: Write an expiration date on the O2 sensor cell that is one year from the date it is removed from its packaging. Page 10

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Section 5 Modes of operation Mode

Action

Indicator light color

Sleep

Unit not in operation, display in sleep mode

Amber

Standby

Unit not in operation, input parameters can be adjusted

Amber

Run

Unit operating, warming to set point temperature

Flashing green

Unit operating at set point

Solid green

See Appendix for a description of the software operating modes. 6/10/2008

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Section 6 Initial assembly

Section 7 Setting up

Certain accessories must be installed in the Precision Flow™ unit before it can be used. These will normally be supplied in a separate package from the main unit as some are country-specific. The power cord plugs into the IEC320-compliant receptacle on the rear panel.

7-1.

Connect power cord if it is not already in place.

7-2.

Hang the sterile water from IV pole hook.

7-3.

Attach the unit to IV pole below lowest point of the sterile water.

6a. Oxygen sensor installation

NOTE: The Precision Flow™ oxygen and air supply inlet fittings are gas-specific to ensure correct connection.

CAUTION: The oxygen sensor is in a sealed package. Un-sealing the package admits oxygen to the sensor, which should be replaced after1 year. Do not open the package until the unit is to be used. Write the expiration date on the oxygen sensor cell.

WARNING: Unit weighs 12 lbs.(5.4kg) To prevent possible injury or damage from falling, it must be securely fixed to a 5-wheel IV pole, with the base of the unit not more than 40” (102cm) above the floor. Fixed rail supports may also be used.

1. Remove three (3) securing screws from the access panel. Pull the panel away from the unit. 2. Insert the threaded end of oxygen sensor into port, and screw into place. Sensor should be hand-tight only. Do not use tools. 3. Plug sensor cable into connector. Replace cover. Do not over-tighten screws. 6b. Inlet gas filter trap assemblies.

Oxygen Sensor Access Panel

Gas filters and traps are supplied in a separate container with the O2 sensor and must be installed before first-time use. The filter and trap assemblies have a quick-disconnect fitting which connects to the main unit, and a DISS gas fitting for either an oxygen or an air hose. Note: The quick-disconnect tubes for the oxygen and air filters are different sizes, so that they can not be connected incorrectly.

7-4.

Connect oxygen and air supply hoses to correct inlets, then connect them to the wall outlets.

7-5.

Open the bags containing the disposable water path, cartridge and delivery tube, and assemble them as follows: 7-5-1. Install a high or low-flow vapor transfer cartridge in disposable water path as shown. The cartridge may be inserted either way up. Align the cartridge ports with the disposable water path openings and press firmly into place.

Pole clamp

Oxygen

Power cord Air

Disposable water path

WARNING: Never attempt to run the Precision Flow™ unit without the inlet gas filters. Particles in the inlet gas flow will cause irreparable damage to the mass flow sensors.

Cartridge

Installing the gas inlet filters 1. Remove any protective tape from the gas inlet connectors at the back of the main unit. 2. Push the filter assembly firmly in the correct connector opening until it is fully engaged and it clicks. The filter should rotate but not pull out. Removing gas inlet filter assembly from main unit Note: It is not normally necessary to remove the filter and trap assemblies, but shipping and packing are easier if the filters are detached first. 1. Press the filter assembly into the main unit.

Disposable Water path openings

Cartridge Installed

Ports

2. Using forceps or hemostats, hold the locking ring in place against the main unit backplate. 3. Pull the filter assembly straight out. Page 12

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Section 7 Setting up

Section 7 Setting up

7-5-2. Fit the delivery tube to the disposable water path as shown. Press firmly into place.

7-6. Inserting disposable patient circuit: 7-6-1. Open door by sliding it forward to expose the docking station. 7-6-2. Hold disposable patient circuit by its handle, with the delivery tube downward as shown. 7-6-3. Slide disposable patient circuit downward into the docking station until it stops.

Insert fully. Both latches must click shut.

6-6-4. Close door by sliding it backward until it stops. Tube clamp Water inlet tube

Spike

Assembled disposable patient circuit ready for insertion.

NOTE: If the sliding door does not close easily, check that the cartridge is installed correctly and the disposable water path is fully inserted into the docking station. Patient delivery tube Page 14

CAUTION: Do not remove the disposable patient circuit while the unit is operating. 6/10/2008

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Section 7 Setting up

Section 8 Adjustments

WARNING: Use high–flow cartridge for flows 5-40 lpm and low-flow cartridge for flows 1-8 lpm.

Flow, oxygen % and temperature are all adjusted using the setting control knob in the center of the front panel.

7-7. Plug in power cord, and check that all the display indicators light. The Precision Flow™ goes through a self-test: • all icons and numeric displays light up for 10 seconds • internal sensors and control systems are checked • if no faults are detected the unit enters STANDBY mode • “Water Out” icon indicates there is no water in the disposable water path • status LED is amber 7-8. Rotate the control setting knob in either direction to light up the display in STANDBY mode. 7-9. Press the Mute button to change between bright and dim display (this function is only available if no alarms are active). 7-10. To connect the sterile water, remove spike cap and wipe spike with 70-90% isopropyl alcohol. Firmly insert spike into spike port of the sterile water, avoiding direct hand contact. Unclamp the water inlet tube so that water flows into the disposable water path and the “Water Out” alarm cancels.

8-1. To enter Adjustment mode, press and release the setting control knob. One displayed value will flash to show that it is selected for adjustment. Press the knob repeatedly to cycle the active selection through flow, oxygen % and temperature. 8-2. To change the selected variable, rotate the knob until the desired value is displayed. Press the knob again to enter this value and select the next variable. 8-3. If the knob is not rotated for five (5) seconds, the unit returns to the normal Run mode. To re-enter Adjustment mode, press the knob again. Rotating the knob has no effect unless one of the settings has been selected and one of the displayed values is flashing. NOTES on settings: • When gas inlet pressures are less than 40 psi (276 kPa) the full specified range of flows and Setting control knob oxygen mixtures is not available. The Precision Flow™ detects the actual inlet pressures and calculates the range of values that can be achieved. An alarm sounds if the operator attempts to make settings outside this range.

7-11. Press Run/Standby button to start gas flow, pump and heater. Press twice if the display is initially blank. Check that the unit beeps while it tests the disposable water path and pump (see Notes below).

• If oxygen is disconnected, the blender setting will be fixed at 21%. If air is disconnected the setting is fixed at 100%. An audio signal sounds if the operator attempts to set any other value.

7-12. If all tests are passed the unit enters RUN mode. Water circulates and fills the delivery tube. The three numeric displays for flow, temperature and oxygen % display initial factory settings or the last settings used. The Status LED flashes then shows continuously green Run/Standby button when the unit reaches desired temperature.

• If a HIGH-FLOW cartridge is installed the flow can not be set below 5 lpm. • If a LOW-FLOW cartridge is installed the flow can not be set above 8 lpm. NOTES on adjustment:

NOTES on startup: • When the Run/Standby button is pressed, the unit enters a detection mode. A prompt sounds and the disposable water path icon flashes for approximately five seconds. In this mode the unit inspects the disposable water path to confirm that: a cartridge is present; the disposable water path is present; and the water level is correct. Power is then applied to the water pump. After five seconds the unit checks that the water pump has started and is running at the correct speed. • The “low water” icon may flash intermittently until the water system has filled.

• If the FLOW setting is rapidly adjusted downward, the temperature display may show a transient increase. This occurs because the heater temperature takes a few seconds to adjust to the lower heat output required for the lower gas flow. The transient temperature increase occurs only adjacent to the heater plate and is not reflected in the temperature of the delivered gas. • During Warmup the temperature display shows actual temperature, not the set value. • In Run mode the display shows the current set values for flow, oxygen % and temperature. • The setting control knob is sensitive to speed. Rotate quickly for large increments and slowly for small increments.

• Purging of air bubbles from the circulation can not be seen, because the gas escapes through a membrane, not into the water container.

Section 9 Connecting to patient

• Clamp the inlet tube to stop the flow of water into disposable patient circuit whenever the unit is in standby mode.

9-1. Wait for desired set temperature to be reached before placing the cannula on the end of the patient delivery tube. The flashing green Status LED becomes steady when the set temperature is reached.

To adjust settings: See section 8 (Adjustments)

9-2. Check water level, temperature display, gas flow rate, and oxygen percentage.

For alarms and troubleshooting: See section 12 (Alarms) Page 16

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Section 9 Connecting to patient

Section 11 Inserting & changing the disposable patient circuit

9-3. Size cannula to patient by ensuring that nasal prongs do not fit tightly into nares. 9-4. Attach correct sized cannula for the patient and cartridge onto the delivery tube. Adjust the flow to the desired rate and fit the cannula to the patient. Flow ranges are shown in the table: Cartridge

Cannula type

Operational flow rates

High Flow

Adult

8-40 lpm

High Flow

Pediatric

5-20 lpm

Low Flow

Premature, neonatal, infant, intermediate infant

1-8 lpm

WARNINGS: • Always follow aseptic technique (including proper hand washing and avoiding direct hand contact with connection points) when setting up the Precision Flow™ and Standard Precautions when placing on a patient. • Cannula should not obstruct the nares of the patient. • Change nasal cannulas when soiled.

The disposable patient circuit, consisting of the disposable water path, cartridge and delivery tube, is marked for single patient use and must not be re-used. They may be used for up to 30 days on a single patient but must then be replaced. 11-1. Stop the unit by pressing the Run/Standby button. 11-2. Clamp the water inlet tube connected to the sterile water, and disconnect it by pulling out the spike. 11-3. Slide the door forward to expose the disposable water path. 11-4. Lift the disposable patient circuit out of the Precision Flow™ unit and discard in accordance with institutional guidelines. 11-5. Wipe down the docking station with 70-90% isopropyl alcohol wipes.

NOTES: • The cannula or other interface should be connected to the patient only when the unit has warmed to set temperature (temperature display stops flashing). • Droplets of condensation may appear at the end of patient delivery tube while unit is warming up. This is normal and will stop within a few minutes when set temperature is reached and the cannula is fitted to the patient. • Some condensation around the nose is possible. In addition, a high moisture level may mobilize mucus from nose and sinuses. Make sure patient has a supply of tissues.

Section 10 Operations: General Guidelines WARNING: Never connect the unit to a patient until it reaches set point temperature (temperature display stops flashing). Allow the unit to warm-up to purge condensate and prevent patient discomfort due to cold or partly humidified gas. 10-1. Check that water is properly circulating through the machine by making sure the patient delivery tube is warm across the entire length. If good circulation cannot be confirmed, check that the water flow is not obstructed by air bubbles in the patient delivery tube. 10-2. Check that the patient delivery tube will not be occluded by the patient’s position or moving bed structures. 10-3. Take precautions to minimize cooling of the unheated cannula by trying to maintain contact with the patient’s skin and insulating the exposed portion of the cannula with bedding. 10-4. Slide cover for the disposable water path closed during operation. 10-5. Check that nothing blocks the vent on the back of the unit. 10.6 For optimum operation, stand facing the front of the unit at a distance that permits you to easily read the display and reach the controls (<1m). NOTE: Condensation in the cannula may occur in certain ambient conditions at flow rates less than 5 lpm (low flow cartridge) or less than 10 lpm (high flow cartridge). To minimize condensation it is recommended not to set the temperature higher than 34°C, if using flow rates less than 5 lpm. Page 18

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WARNINGS: • The heater plate in the docking station may be hot ! • Universal precautions and aseptic technique must be used in handling the disposable parts.

11-6. Open a new cartridge, delivery tube and disposable water path. 11-7. Install the cartridge in the water path as described in Section 7 (Setting up).

CAUTIONS: • The sensor windows in the docking station must not be scratched or damaged. If necessary, clean them only with alcohol wipes (70-90% isopropyl alcohol). Never use abrasive cleaners, bleach or organic solvents.

11-8. Slide the disposable patient circuit into the docking station and close the sliding door. 11-9. Hang a new sterile water on the IV pole hook. 11-10. Wipe the spike on the water inlet tube with 70-90% isopropyl alcohol and insert into spike port of the sterile water. 11-11. Re-start the unit. 6/10/2008

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Section 12 Alarms

Section 12 Alarms

Fault conditions are indicated by icons displayed on the front panel and by audio signals.

Alarm Table

• Unless indicated otherwise, alarms will self-clear when the fault condition is corrected. • The MUTE button will silence low priority alarms for 2 minutes and medium priority alarms for 20 seconds. • A yellow LED above the Mute button indicates that one or more alarms are muted. FLOW display in liters/min

OXYGEN %

Battery low or charging Disposable water path faulty or absent

Low flow cartridge installed Blocked tube

Cartridge alarm

Water low

High flow cartridge installed

General fault

Gas supply TEMPERATURE display in °C

ALARM TONE PRIORITIES • MEDIUM PRIORITY alarms require immediate attention and are indicated by rapid intermittent tones (fast triple beeps). • LOW PRIORITY alarms require attention as soon as reasonably possible and are indicated by infrequent intermittent tones (slow double beeps). In addition to the medium and low alarms, the Precision Flow™ emits the following audio signals: • single dull tone that sounds when the unit switches from run to standby mode • single high pitched beep whenever you press the control setting knob • low pitched buzz when you try to change a setting that cannot be changed or when alarm conditions prevent entering the run mode • slowly repeating single beep during disposable water path testing Page 20

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Section 12 Alarms

Section 13 Shut down

Alarm Table

13-1. Stop the unit by pressing the Run/Standby button. Unit will enter Standby mode. 13-2. Clamp the water inlet tube, and disconnect it by pulling out the spike. 13-3. Open the sliding door, remove the disposable water path with cartridge and delivery tube attached by sliding it upwards out of the docking station. 13-4. Discard all disposables according to hospital guidelines. 13-5. Disconnect unit from AC power. Note: The Precision FlowTM has no ON/OFF switch. Plug the unit into a wall socket to keep the battery fully charged. CAUTION: Even a fully charged battery will lose its charge over a period of weeks when the unit is not connected to an AC source. It is recommended that the unit is connected to AC for at least two hours once a month to maintain battery charge.

Section 14 Routine maintenance Note: The internal backup battery should not require routine replacement and is not useraccessible. Contact Vapotherm for further information. 14.a Oxygen sensor The oxygen sensor (3000127) should be replaced annually. It is accessible by removing a panel at the back of the unit, and can be changed in a few minutes by the user or biomedical engineer. Use only Vapotherm approved parts. To replace oxygen sensor: 1. Remove three (3) securing screws from the access panel. Pull the panel away from the unit. 2. Disconnect the cable connector: grasp with pliers and pull straight back. 3. Unscrew the sensor body from its housing. Insert new sensor and screw in. 4. Plug in cable and replace cover. Do not over-tighten screws. 5. Apply label to indicate when replacement is due. NOTE: Failures in the control or measurement systems for temperature, gas flow, and oxygen percentage will cause a General Fault alarm indicated by this icon. The unit will not operate in this fault condition. With the exception of O2 sensor replacement, the unit must be repaired by an approved service facility.

CAUTION: Sensor should be hand-tight only. Do not use tools.

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Section 14 Routine maintenance

Section 16 Specifications

14.b Gas filters and traps It is recommended that the inlet gas filters be replaced every 6 months.

PHYSICAL CHARACTERISTICS Dimensions: Height 11.5”(300mm), width 8”(200mm), depth 7”(180mm), excluding IV pole clamp and gas filters.

To change the filter element:

Weight: 12 lb (5.4 Kg) without disposable patient circuit Circulating Water Volume: 400 ml approx. including delivery tube and cartridge. Mounting: Rear mounted clamp fits IV poles up to 1.5”(38mm) diameter. Gas Connections: Standard DISS non-interchangeable fittings for medical air and oxygen.

1. Unscrew trap bowl to expose filter element. 2. Unscrew black retaining core to release filter assembly.

FUSES: (Qty 2) GMA 3A F250 V 5mm x 20mm

3. Pull off and discard old filter element. Install new element by pressing it on to the black plastic retaining core. Use only Vapotherm approved parts. Fit the aluminum washer over the threaded end of the core.

SYSTEM REQUIREMENTS Power: 100-240VAC, 50-60Hz, approx. 200VA during warm up, approx. 80VA in steady state (depends on flow rate and temperature).

4. Screw the assembled filter element into the housing. Replace the clear plastic trap bowl.

Back-up power: (Qty 4) 4.8V nickel-metal hydride AA batteries (not user replaceable).

CAUTION: The trap bowl must be screwed tightly into the housing to prevent gas leaks.

Gas supply: Medical air and oxygen at inlet pressures between 4 and 70 psi (28-482 KPa).

14.c Fuses The mains fuses (two GMA - 3A F250 V, 5 x 20mm) are located next to the power cord inlet. Use a small flat blade screwdriver to pry open the fuse compartment door to access fuses. No other routine maintenance is required within the first three years of service. There are no other user-serviceable parts. Internal sensors are self-calibrating. Failure to self-calibrate will cause a general fault condition requiring repair.

Section 15 Cleaning and disinfection The entire patient circuit is disposable and no disinfection is required. The main unit, including the docking station for the disposable water path should be wiped down with 70-90% isopropyl alcohol wipe after use. Unplug the Precision FlowTM while cleaning and disinfecting. NOTE: The transparent sensor ports in the docking station must be clean. The unit will not operate if the sensors do not receive a clear signal.

CAUTION: Do not use bleach, organic solvents or abrasive cleaners. Page 24

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NOTE: the full range of flows and oxygen percentage is available only if both gases are present at inlet pressures of at least 40 psi (276 kPa). Water: Sterile water in pre-filled sealed container. PERFORMANCE Temperature: Range- 33 to 43°C at exit from the delivery tube, adjustable Resolution- 1°C Accuracy- ± 2°C Warm up time: ± 1°C of 33°C set point < 5 minutes (at ambient 23°C) Humidification: >95% at up to 20 lpm; >90% at 20-40 lpm Oxygen percentage: Range- 21 to 100% O2 Accuracy- ± 2% Resolution- 1% 6/10/2008

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Section 16 Specifications

Appendix

PERFORMANCE Flow rate:

Audio Tone Characteristics

STANDARDS Designed to conform to the following standards: IEC 60601-1 UL60601-01 CSA C.22.2/No. 601.1 AS/NZS 3200.1.2 EN60601-1 ISO 8185 ENVIRONMENTAL Operating Ambient temperature: 18-30°C Ambient relative humidity: 0-90% RH non-condensing Ambient Pressure: Standard atmospheric – Not to be used in hyperbaric conditions Storage and Shipping Ambient temperature: -10 - +50°C Ambient relative humidity: 20-90% RH ALARM SOUND PRESSURE RANGES Medium Priority Alarm 47 dB measured 1m from unit Low Priority Alarm 45 dB measured 1m from unit

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Appendix

Appendix

Software operating modes Guidance and manufacturer’s declaration - electromagnetic emissions The Precision Flow™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Precision Flow™ should assure that it is used in such an environment. Emissions test

Compliance

RF emissions CISPR 11 RF emissions

Group 1

Class B

CISPR 11

Electromagnetic environment- guidance The Precision Flow™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby equipment. The Precision Flow™ is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Class A

Complies

Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigating measures, such as re-orienting or relocating the Precision Flow™ or shielding the location.

IEC 61000-3-3

Guidance and manufacturer’s declaration- electromagnetic immunity IEC 60601-1-2:2001+A1:2004 EN60601-1-2:2001 AS/NZ3200.1.2:2005

The diagram illustrates the operating modes for the unit. • Immediately on connection to AC power a POST (Power-On Self Test) is run to verify proper function of subsystems, sensors and actuators in the Precision Flow™. • On successfully completing the POST the unit enters STANDBY unless there is a test failure, when the system alarms, enters FAULT mode and can not be started. • The Precision Flow™ enters RUN mode from STANDBY when the RUN/STANDBY button is pressed. Normal operation starts. The pump, heater and gas flow proportioning systems start. Sensors and alarms are active and flow, temperature and oxygen % can be set. • To return to STANDBY, the RUN/STANDBY button is pressed again. • If AC power is disconnected when the unit is in RUN mode it enters BATTERY mode. If the battery is fully charged, gas mixing and metering continues for at least 15 minutes, but water is not circulated or heated. When the battery is discharged the unit enters the POWER OFF mode.

Sub Test

Passed Parameters

Electro-Static Discharge EN 61000-4-2:1995,+A1:1998, +A2:2001

±6kV Contact discharge ±8kV Air discharge

Radiated RF Susceptibility EN 61000-4-3:2002

80- 2500MHz @ 3 V/m, 1kHz AM 80% modulation

Electrical Fast Transients EN 61000-4-4:2004

±5kV AC mains,

Surges EN 61000-4-5:1995, +A1:2001 Line Conducted RF Susceptibility EN 61000-4-6: 1996, +A1:2001 Power Frequency Magnetics EN 61000-4-8: 1993, +A1:2001 Voltage Dips and Dropouts EN 61000-4-11: 2004

±0.5,1kV Line to line ±0.5, 1 2kV Line to protected earth 0.15-80MHz @ 3Vrms, 1kHz AM 80% modulation 3A/m @ 50/60Hz PASSED Per Standard

• If AC power is disconnected in STANDBY, the unit enters POWER OFF mode. • If the RUN/STANDBY button is pressed when in BATTERY mode the unit enters POWER OFF mode. Page 28

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Warranty Vapotherm expressly warrants, for a period of one (1) year from the date of purchase by the initial purchaser of the Product (“Customer”) that the Product shall meet the specifications set forth in the applicable official instructions for use provided with each Product (the “Instructions”). The sole remedy for this warranty is that Vapotherm shall repair or, at its option, replace any part or all of any Product that is defective at no cost to the Customer. Vapotherm shall pay any shipping charges required in repairing or replacing any part or all of a Product provided that such Product is shipped within three (3) months of the date of purchase by the Customer. Thereafter, shipping charges shall be paid by the Customer. This warranty does not apply to any patient circuit or hoses supplied with the Product nor does the warranty cover abuse or misuse of the Product, or damage due to unauthorized servicing. To maintain this warranty, repair may only be performed by Vapotherm or a Vapotherm certified service center. The warranty set forth in this shall become null and void if the Product is opened, otherwise tampered with, or if repairs are attempted by anyone other than Vapotherm or a Vapotherm certified service center, or if the Product is operated by anyone other than trained and duly qualified medical personnel. EXCEPT AS EXPRESSLY SET FORTH IN SECTION [4.1], VAPOTHERM MAKES NO WARRANTY, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE PRODUCTS OR ANY OTHER ITEMS PROVIDED BY VAPOTHERM OR OTHERWISE IN CONNECTION WITH THIS AGREEMENT, AND HEREBY EXPRESSLY DISCLAIMS ANY OTHER FORM OF WARRANTY, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THIS STATED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES PROVIDED BY LAW.

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