Manujet III Instructions for Use March 2013

English General Information The Manujet III is a manually controlled oxygen delivery system used for transtracheal ventilation. It is recommended for emergency rooms, crash carts, ambulances and operating rooms as it offers a quick and efficient oxygenation of a patient. Intended Use The Manujet III is designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. Ventilation is achieved in conjunction with a transtracheal catheter, or cricothyrotomy device, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter.

Caution: • Maximum operation pressure is 4 bar (58 psi). The pressure regulator and gauge ensure that the maximum operation pressure of 4 bar (58 psi) is not exceeded. • Total airway obstruction is a contra-indication for this device because exhalation can not take place. The device is not intended for infants or neonates. • User is responsible that the oxygen source is without particle.

Emergency use via transtracheal ventilation • As a life saving manoeuvre in the “cannot intubate – cannot ventilate“ situation for oxygenation to avoid a severe desaturation of the patient. • For prehospital use if there is a partial obstruction of the upper airway. In emergency situations the Trans Tracheal Jet Ventilation (TTJV) has fewer complications, and is faster and simpler as a surgical cricothyrotomy. Elective use • Microlaryngoscopy • Rigid bronchoscopy • To assist a difficult fibreoptic intubation • Predicted difficult extubation

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English Safety Instructions • Ventilation values mentioned in this instruction for use cannot be compared with the ventilation via a cuffed Endotracheal Tube due to the loss of air through the upper airway. • When ventilating with the Manujet III, the patient needs to be observed all the time. Pulse oximetry or chest movement may indicate successful ventilation. As the Manujet III is a manual device the user has to take responsibility. • The user must ensure that expiration takes place via the upper airways. A total obstruction means a contraindication for the use of the Manujet III with Jet Ventilation Catheter. If another way of securing the airway is not possible and expiration is not assured, ventilation frequency should be reduced to 3 strokes per minute to avoid barotrauma. This can be sufficient as a life saving manoeuvre in case of a total upper airway obstruction. • The use of the Manujet III is not recommended for Infants or Neonates and should only be used as a life saving manoeuvre. In such a case every stroke must be limited to max. 1 second (0.4 - 0.8 bar / 6 - 12 psi). • FIRE HAZARD: Oxygen that flows through the Manujet III is not flammable by itself. However oxygen acts as a fire accelerant. • Make sure that damaged high pressure hoses and damaged small bore tubings are not used. Before each use a complete function check must be carried out. Connect the device to the oxygen source. Every ventilation pressure from 0 - 3.5 bar (0 - 51 psi) must be adjustable and a ventilation must be possible. • Do not connect the Manujet III to an IV-cannula. Caution: Federal Law restricts this device to sale by, or on the order of, a physician. For USA and Canada only. Warning • Before use, carefully read this manual with the safety instructions. • The product must only be used by physicians trained in its use. Training material is available upon request from the manufacturer. • If disconnecting from the oxygen source make sure to always disconnect at the gas probe. Instruction for use 1. Connect the Manujet III to the oxygen source. 2. Pull the pressure regulator knob and turn it counter clockwise until the pointer on the gauge is at 0 bar / psi. Release the pressure in the system by pressing the trigger. 3. Connect the Manujet III to the inserted catheter via the small bore tubing. 4. Adjust the desired ventilation pressure by turning the pressure regulator knob clockwise. Start with the lowest pressure (0 bar/psi) and afterwards increase this pressure slowly under ventilation and clinical control of chest movements. The adjusted ventilation pressure is displayed on the gauge. Push the pressure regulator knob for locking. To re-adjust the pressure pull the pressure regulator knob and adjust to the desired pressure. 5. By pressing the trigger the patient can be ventilated continuously. Ventilation pressure and ventilation frequency must be adjusted properly to achieve balanced ventilation. The following minute volumes are delivered to the patient considering an in- and expiratory ratio of 1 to 1: (This information is only valid for elective use, open airways and for the use with VBM Jet Ventilation Catheters): Catheter Ventilation frequency [1/min] Ventilation pressure [bar / psi] Volume [l/min] 14 G 20 - 30 2.0 / 29 16 - 21 13 G 12 - 13 3.5 / 51 24 - 30

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English Device Delivery Version Manujet III standard

Manujet III with NIST-O2

The Manujet III (standard) is supplied with a 4 m (13 ft.) The Manujet III with NIST-O2 fitting (without high pressure hose assembly and a 100 cm (40 inch) high pressure hose assembly) is supplied with small bore tubing (with Luer Lock fitting). a 100 cm (40 inch) small bore tubing (with Luer Lock fitting).

Small bore tubing

Luer Lock fitting Gauge

Trigger (On/Off Valve) Gas probe

Pressure regulator

High pressure hose NIST-O2 fitting Not for sale in USA and Canada.

Gas probe Country

Gas probe

Germany

Combination plug oxygen/compressed air DIN 13260

USA

DISS O2

France

NF S 90-116 O2

All other countries are supplied without gas probe. The professional choice and attachment of the pressure hose / gas probe rests with the user. Technical Data Oxygen source pressure:

4 - 10 bar (58 - 145 psi)

Adjustable ventilation pressure: 0 - 3.5 bar (0 - 51 psi) Display accuracy:

± 0.05 bar (± 0.72 psi)

Color coded scale: --yellow --blue

1 - 2.5 bar (14.5 - 36 psi) 2.5 - 4 bar (36 - 58 psi)

Operating pressure must not exceed 4 bar (58 psi).

Dimensions (case):

height: 100 mm ( 4 inch) width: 400 mm (16 inch) depth: 300 mm (12 inch)

Weight with case and accessories: --Manujet III standard 1.80 kg (60 oz) --Manujet III with NIST-O2 1.24 kg (40 oz) Environmental conditions: --Transport/Storage: --Operation condition: -9-

+ 5°C...+ 40°C (41°F - 104°F) + 10°C...+ 40°C (50°F - 104°F) 30...95 % rel. atmospheric humidity without condensation

English Cleaning Instructions Cleaning process should follow institution standard procedures. For disinfecting the device can be wiped externally with a non-flammable disinfectant solution (e.g. Sani-Cloth® Active, company Ecolab). Do not immerse the device in fluids. The device cannot be automatic cleaned respectively sterilized. Attention: Do not clean the device with flammable substances. Do not clean the glass of the gauge (plastic material) with aggressive agents. Small bore tubing is for single use only and must not be reused. Metrological Inspection The accuracy of the Manujet III Gauge must be checked every 24 months. If there is an indication that the Manujet III Gauge cannot keep the accuracy of measurement within the 24 months, or the metrological characteristics of the Manujet III Gauge have been affected, a metrological control has to be carried out immediately. This has to be carried out only by a person who meet the requirements for metrological controls. The results of the control, as well as the measured values and measurement procedures has to be documented. After successful control, the Manujet III Gauge has to be marked with a sign which indicates (clearly and traceable) the year of the next inspection and the person who carried out the metrological control. In order to check the values, the Luer Lock fitting of the Manujet III has to be connected to a calibrated pressure gauge (measurement accuracy of min. ± 0.016 bar / ≈ 0.232 psi). Inflate the Manujet III to 1, 2, 3 and 3.5 bar and take a note of the values. The values must be in the tolerance of ± 0.05 bar (± 0.72 psi). If this is not the case, the device must be returned to VBM for service. If the values are within the tolerance, the device can still be used. If required measuring equipment is not available, the metrological control can be carried out by VBM. In this case the Manujet III has to be sent to VBM. Note for conversion of bar to SI-Unit Pascal: 1 bar = 100 kPa Life Span Considering a correct use of the product the life span for the Manujet III is 8 years. Disposal Waste management of devices or spare parts has to be carried out according to valid local legal regulations. Service The medical device may only be serviced by persons who have the technical knowledge, qualification and the required means to properly carry out the service. After service of the medical device, the essential constructive and functional characteristics for safety and functionality have to be checked, insofar as they can be influenced by the service procedure. All warranty claims will be lost, if the user or an unauthorised service agency have attempted to effect repairs which are not described in this instruction of use. To ease repair of the medical device, return it together with a detailed description of the defect. As a protective measure for the safety of VBM staff return any medical device completely cleaned and disinfected (see “Cleaning Instructions”). The VBM Service is entitled to refuse the repair of contaminated items for safety reasons. Repair The glass of the gauge (REF 52-03-903) can be easily replaced using a screw driver (a). The chapter „Metrological Inspection“ must be considered. a

Maintenance The Manujet III is maintenance-free if operated and handled properly. - 10 -