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richiesta Codice offerto Descrizione BD/RDM CND

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(pz)

Prezzo unitario

offerto

Prezzo totale offerto

250 355-001-010E

Medisize filtro HME Hygrovent Gold Comfort

BD/RDM: 169860 CND: R040102 25

IMPORTO TOTALE DELLA FORNITURA – LOTTO 22:

In caso di aggiudicazione la ditta Betafin Spa, per l’intera durata del contratto, fornirà in comodato d’uso gratuito nr.6 sistemi di umificazione Booster Hygrovent Gold.

CONDIZIONI DI FORNITURA

- Pagamento: 60 gg. data fattura;

- Prezzi IVA esclusa 22% a Vs. carico;

- Imballo, trasporto e consegna: a ns. carico c/o Vs. sede entro 10 gg. data ordine;

Matera, 28/07/2020.

S S S C C C H HE H E ED D DA A A T T T E EC E C CN N N I IC I C CA A A

Data emissione: 08/11/2010 Revisione: 2

Pg. 1 Redatto da: Gualtiero Piana Verificato da: Gualtiero Piana Approvato da:

Resp. Qualità Gualtiero Piana

“

“M M

H H M M E E H H

G G

C C

” ”

Nome Commerciale: Medisize filtro HME Hygrovent Gold Comfort

Codice: 355-001-010

Descrizione prodotto /

Caratteristiche Tecniche: Medisize Hygrovent Gold Comfort è composto da:

- un filtro HME con integrati: un alloggiamento per l’unità di riscaldamento; un’apertura per l’ingresso dell’acqua che consentono la somministrazione di ulteriori quantità di umidità e calore

- un Catetere Mount PVC 10 cm. con Cobb girevole doppia apertura

L’ alloggiamento per l’unità di riscaldamento è composto da:

- Policarbonato

- Membrana in Gore-tex® (PTFE+Poliestere), misura dei fori 0,2 micron

- Griglia in alluminio Filtro HME:

Non conduttivo

Filtrazione di tipo elettrostatico e meccanico:

Capacità di rimozione batterica: 99,99%

Capacità di rimozione virale: 99,99%

Superficie filtrante: 20cm²

Materiale filtrante: polipropilene elettrostatico, non rilascia particelle

Materiale dell’alloggiamento: Stirene Butadiene Materiale HME: Carta di cellulosa con CaCl2

Calo di idratazione:

- 3 mg H2O/l air (ISO 9360) a 250ml - 4 mg H2O/l air (ISO 9360) a 500ml - 6 mg H2O/l air (ISO 9360) a 1000ml Caduta di pressione:

- <1,6 hPa (ISO 9360) a 30 l/min catheter mount incluso - <3,7 hPa (ISO 9360) a 60 l/min catheter mount incluso - <5,3 hPa (ISO 9360) a 90 l/min catheter mount incluso Volume del filtro: 59ml escluso innesto a catetere

Peso: 62g Connessioni:

22M/15F lato paziente con catheter Mount incluso 22F/15M lato macchina

Corredato di presa Luer lock per capnografo

Corredato di presa Luer lock sul tubo da 1,5 x 3,1mm per la somministrazione di acqua sterile

Catheter Mount:

Materiale: PVC

Superficie interna liscia

Raccordo di Cobb doppio girevole

S S S C C C H H H E E E D D D A A A T T T E E E C C C N N N I IC I C CA A A

355-001-010

Pg. 2

Doppia apertura per broncoscopia e broncoaspirazione Connettori saldati e a perfetta tenuta, 22F

Lunghezza: 10cm

Flessibile in modo da consentire angolazioni fino a 360° senza modificare il lume interno

Compliance inferiore al 2% del volume

DEHP Free ad esclusione del tubo per la somministrazione di acqua sterile e del catheter mount

CND R040102 GMDN 46816 N° Registrazione Repertorio MDS 169860

Durata: Utilizzo consigliato 24 ore. Studi clinici dimostrano che l’utilizzo di Hygrovent Gold può essere esteso fino a 48 ore senza alterarne le capacità filtranti e umidificanti.

Destinazione d’uso: Filtro autoumidificante per anestesia / rianimazione da utilizzare collegato ad una fonte d’acqua sterile e all’unità di riscaldamento.

Marcatura CE: CE 0344

Classe CE: II a

Riferimenti normativi: Prodotto conforme ai requisiti della Direttiva 93/42/CEE

"Dispositivi Medici" - D.P.R. 46/97 Confezionamento: Singolo sterile

Confezione di vendita: 25 pz

Sterilizzazione: Ossido d'Etilene (ETO)

Validità: 5 anni dalla data di sterilizzazione a confezione integra e non danneggiata

Presenza di lattice: Latex free

Prodotto da: Medisize B.V.

Stabilimento di: Hillegom (Olanda),

certificato ISO 9001:2000 e EN ISO 13485:2000 Distribuito da: Medisize Italia Srl con unico socio

Breve introduzione all’umidificazione:

Per massimizzare le difese del polmone è necessario somministrare un livello di umidità ottimale e ridurre l'esposizione agli agenti contaminanti.

Mantenendo un livello di umidificazione ottimale si minimizza l'impatto con i contaminanti che invadono le vie respiratorie permettendo di:

- aumentare la rimozione - ottimizzando il sistema di trasporto mucociliare si favorisce la rimozione degli agenti contaminanti.

- limitare la replicazione - prevenendo la formazione di accumulo di muco, si evita la formazione dell'ambiente ideale per la replicazione di agenti patogeni.

HYGROVENT GOLD è un nuovo presidio medico per l’umidificazione attiva.

Perché usare Hygrovent Gold

* Semplice (plug & play) e sicuro

* Ridotta resistenza al flusso e ridotto volume

* Non si forma condensa

* Minor rischio di contaminazione dovuto alla formazione di condensa nei circuiti

* Risparmio di tempo :

o No raccoglicondensa o No manutenzione

o Non necessita di settaggi perché il sistema è completamente autoregolante

* Efficace, nelle situazioni di normotermia raggiunge livelli di umidificazione prossimi a quelli di un umidificatore attivo (AH 37.8mgH2O/L; RH 99%)

* Anche nelle situazioni in cui gli HME trovano limiti di impiego, come nei casi di ipotermia, difficile controllo della CO2, difficoltà nello svezzamento e secrezioni ispessite può essere utilizzato, in quanto garantisce un adeguato livello di umidificazione

* Rimane escluso l’impiego in neonatologia

* Più economico di un sistema attivo

* Prodotto brevettato ed esclusivo di Medisize

HYGROVENT GOLD È LA NUOVA SOLUZIONE PER L’UMIDIFICAZIONE AD ALTA INNOVAZIONE TECNOLOGICA

Cos’è Hygrovent Gold

Come funziona

Il riscaldatore raggiunge una temperatura di 118°C (temperatura di evaporazione dell’acqua).

Il capillare grazie ad una sezione appositamente studiata consente la diffusione della giusta quantità di acqua per un’umidificazione ottimale 3ml/h.

La membrana in Goretex® con maglie appositamente calibrate da 0,2 micron regola automaticamente la quantità di acqua e costituisce una protezione del riscaldatore da possibili contaminazioni batteriche e virali della piastra di riscaldamento.

=

Sistema HME con alloggiamento per Booster riscaldatore, capillare con raccordo luerlock per il collegamento ad una sacca di acqua sterile e speciale membrana in Gore Tex

+

Unità di riscaldamento controllato per l’evaporazione dell’acqua (118°C)

Efficacia di Hygrovent Gold vs Umidificazione passiva

In condizioni normotermiche (34°C)

* = p < 0.05

Condizioni ipotermiche (28°C)

28,13

28,28

28,46

26,37

27,1 27,1

26,61

27,1 27,2

24,5 25,5 26,5 27,5 28,5

5 L/min 10 L/min 15 L/min

Hygrovent Gold Hygrobac Hygrovent S

36,86

36,31

35,69

32,57

33,9

33,55 33,99 33,78

31,95

29 30 31 32 33 34 35 36 37 38

5 L/min 10 L/min 15 L/min

Active gold Hygrobac Hygrovent S

*

*

*

*

*

*

*

* *

*

* *

*

* * * *

*

Hygrovent Gold garantisce un livello di umidificazione superiore rispetto ai sistemi HME. Tale differenza è statisticamente significativa

Efficacia di Hygrovent Gold vs Umidificazione attiva

32,75

35,61

36,43

30 31 32 33 34 35 36 37

Filter F&Paykel Hygrovent Gold

Filter F&Paykel Hygrovent Gold

Hygrovent Gold consente una umidità assoluta minima superiore a

quella dell’umidificatore attivo

Quando usare Hygrovent Gold

* ICU

* Anestesia in interventi medio lunghi

* NIV (Ventilazione Non Invasiva)

Come usare Hygrovent Gold

* Gli studi dimostrano che un sistema Hygrovent Gold garantisce prestazioni ottimali

per almeno 24 ore e secondo recenti studi fino a 48 ore.

Respiratory gas humidification: comparison of different devices Pauline Provost *, Jean Roeseler*

Thierry Sottiaux**

* Cliniques Universitaires Saint Luc 1200 Brussels.

** Clinique Notre Dame de Grâce 6200 Gosselies.

Invasive and non-invasive mechanical ventilation modifies the physiological

humidification and inhaled gas heating process. Different devices for the humidification of respiratory gases can reduce the risk of under-humidification of airways. The aim of our study was to compare gas humidification and heating provided by three different devices, via invasive and non-invasive ventilation. We have compared results obtained with:

- a heat and moisture exchange unit (HME).

- a Booster: a small heated humidifier used in association with an HME.

- a Fisher&Paykel MR 850: traditional heated humidifier with heated wires.

I. Non-invasive ventilation; first and second studies

1. Material and methods

This first non-invasive ventilation study was carried out on 10 healthy subjects.

They were ventilated by means of Inspiratory Assistance (IA) and Positive Expiratory Pressure (PEP) via a SERVO i (MAQUET) intensive care ventilator connected to a nasobuccal mask. The positive expiratory pressure was 5 cm H2O and the positive inspiratory pressure was determined to obtain a tidal volume (VT) between 8 and 10 ml/kg, the maximum pressure being 11 cm H2O. FiO2 was 21% throughout the test.

Mean leakage due to the nasobuccal mask was 9% of the VT using the HME and 4%

using the Booster. This leakage percentage is not significant.

The second study was carried out on 10 further healthy subjects, ventilated via a

specific NIV (BREAS PV102) ventilator pre-programmed at a positive expiratory pressure level of 5 cm H2O and a maximum positive inspiratory pressure of 11 cm H2O.

Measurements were calculated according to capacitance hygrometry. We used a

German prototype measurement device (Transtec Computer), comprising a temperature sensor and a humidity sensor attached via the circuit situated between the patient and the humidifier.

Each subject ventilated at random: dry air, via a Medisize Hygrovent Gold HME, via an HME in association with a Booster and via the Fisher&Paykel MR 850 (with heated wires) which was pre-programmed to provide non-invasive ventilation (chamber pre-

programmed at 31°C). A period of 5 to 10 minutes was observed to ensure patient adaptation before recording parameters.

After this adaptation period, the following values were recorded: minute ventilation, inspiratory and expiratory VT, respiratory frequency, minimum, maximum and mean humidity over one minute.

We chose to measure and to compare minimum absolute humidity and minimum temperature (measured at the end of inspiration) between the different devices. These are the minimum values that subjects may be exposed to.

2. Results

a. First study

Minimum humidity

Figure 1 shows a significant difference between the three humidification devices and dry air (10.09+/- 0.33 mg H2O/L). The Booster provides a minimum absolute humidity superior to that provided by the Fisher&Paykel device among all 10 patients (36.24 +/- 0.69), whereas the Fisher&Paykel (34.63 +/- 0.38) is significantly superior to the filter (31.8 +/- 0.76).

Figure 1: Mean minimum humidity in the first study

Minimum temperature

There is a significant difference in gas heating for all three humidification devices compared to dry air (27.15 +/- 0.34 °C). The Booster (33.39 +/- 0.14 °C) produces a higher minimum temperature than the filter (31.56 +/- 0.3 °C) and the Fisher&Paykel (31.95 +/- 0.27 °C), the two latter devices presenting no significant difference when compared with each other. (Figure 2)

booster 36.24 p*=0.00001

p*=0.001 dry air p*=0.025 10.09

p*=0.00001 p*=0.00001

Filter p*=0.001 F&Paykel

31.8 34.63

Figure 2: Mean minimum temperature in the first study

b. Second study

Minimum humidity

According to Figure 3, we observe a significant difference between the three humidification devices and dry air (15.73 +/- 0.54). No significant difference is observed between the absolute humidity provided by the Fisher&Paykel (35.61 +/- 0.58) and that provided by the Booster (36.43 +/- 0.5), both of which provide higher humidification than the filter (32.75 +/- 0.3).

booster 33.39 p*=0.00001

p*=0.00025 dry air NS 27.15

p*=0.00001 p*=0.00001

Filter p*=0.001 F&Paykel

31.56 31.95

Figure 3: Mean minimum humidity in the second study.

Minimum temperature

We observed a significant difference between each of the three humidification devices and dry air (26.2 +/- 0.28 °C). A higher temperature is observed with the Booster (33.12 +/- 0.14). We did not observe a significant difference between the filter (31.43 +/- 0.2) and the Fisher&Paykel (31.48 +/- 0.22) (Figure 4).

Figure 4: Mean minimum temperature in the second study.

booster 36.43 p*=0.00001

p*=0.00001 dry air NS 15.73

p*=0.00001 p*=0.00001

Filter p*=0.001 F&Paykel 32.75 35.61

booster 33.12 p*=0.00001

p*=0.00001 dry air p*=0.00005 26.2

p*=0.00001 p*=0.00001

Filter NS F&Paykel

31.43 31.48

3. Conclusion

In our first two studies, the type of ventilator used did not appear to influence performance. All three humidification devices provide humidification superior to 30 mg H2O/L in NIV and are comparable in terms of humidification efficiency.

The use of HME in non-invasive ventilation is subject to controversy. Indeed, HME represents:

1. an additional dead space in the ventilation circuit.

2. resistance to inspiratory and expiratory flow.

Lellouche et al. Demonstrated that work of breathing (WOB) is higher when ventilating via a filter (WOB =11.3 +/- 5.7 J/min) than when using a heated humidifier (WOB =7.3 +/- 3.8 J/min)¹.

Since direct measurement of work of breathing was not possible in our study, we asked subjects to evaluate ventilation difficulty according to a subjective analogue visual scale.

In our first two studies, greater ventilation difficulty was observed with the filter and with the Booster compared to dry air or to the heated humidifier.

Increased work of breathing among patients can counter the desired effect of NIV. In such cases, we would prefer a heated humidifier rather than an HME.

The three tested devices offer relatively comparable and satisfactory humidification efficiency.

The choice of a humidification device in non-invasive ventilation should take into account the increased work of breathing induced by the filter and the booster.

( ¹ Lellouche F, Maggiore SM, Deye N, Taille S, Pigeot J, Harf A, Brochard L.: Effect of the humidification device on the work of breathing during non-invasive ventilation,

Intensive Care Med. 2002 Nov;28(11):1582-9.)

II. Invasive ventilation; third study

1. Material and methods

The third study was carried out on 10 intubated patients, none of whom presented with COPD. The study was performed using different ventilators: SERVO i (MAQUET), EVITA 2 or EVITA 4 (DRAGER).

Three patients ventilated with inspiratory assistance, two were under SV PEP, one patient was under volume control and three under pressure control.

They ventilated with a tidal volume ranging from 6 to 8 ml/kg. Mean ventilation frequency was 16/min.

The same measurement system was employed.

The 10 intubated subjects were ventilated at random using the Medisize Hygrovent Gold HME, the Booster associated with an HME and with the F&P MR 850 (and heated wires) pre-programmed for invasive ventilation (chamber temperature 37°C). The adaptation time and value recording time were identical to the first two studies.

2. Results

Minimum humidity

Figure 5 shows that the Fisher&Paykel (42.13 +/- 0.38) provides absolute humidity significantly superior to that provided by the Booster (34.09 +/- 0.19), the latter in turn providing superior humidification compared to the filter (32.16 +/- 0.41).

Figure 5: Mean minimum humidity in the third study.

Minimum temperature

The Fisher&Paykel (34.78 +/- 0.24) heats gas more than the Booster (34.09 +/- 0.19).

The Booster heats the gas mixture more than the filter (32.16 +/- 0.41) (Figure 6).

Figure 6: Mean minimum temperature in the third study.

F&K Paykel 42.13

p*=0.000025 p*=0.000025

Filter p*=0.001 Booster 35.96 39.31

F&K Paykel 34.78

p*=0.0001 p*=0.001

Filter p*=0.0001 Booster

32.16 34.09

3. Conclusion

In the third study, we observed higher humidity and temperature values with the F&P. This observation is related to the device’s (non-adjustable) pre-programming (humidifier at 40°C, use of heated wires). We obtained superior humidity and

temperature parameters with the HME-Booster configuration, compared to the HME alone. However, even when used alone, the HME provides inspired air at a temperature superior to 30°C and absolute humidity above 30 mg of water per litre.

There is no current consensus on the choice of a humidification device for invasive ventilation.

The first criterion for humidifier selection should consider contraindications.

The second selection criterion is physician choice based on personal experience.

III. CONCLUSION

We know that heating and humidification of gas mixtures is essential in invasive ventilation and often recommended in non-invasive ventilation.

The results of our three studies are relatively consistent; the temperature and absolute humidity of dry air are logically inferior to those of the three humidification devices.

The three humidification devices offer relatively comparable and satisfactory humidification efficiency. The significance of these results needs to be evaluated.

Should humidified gas to the mucous membrane at 34 mg H2O/L be preferred to 32 mg H2O/L during invasive ventilation via a filter and a Booster?

When leakage is at a minimum, HME and HME-Booster offer efficiency worthy of interest.

Having completed these three studies, certain research prospects are now open to us:

for VT and respiratory frequency, our study sample does not enable the detection of significant differences. A higher study population may, of course, allow such detection.

Measurement of the dead space induced by the filter and the Booster would be of

value. It would also be useful to evaluate the impact of the Booster on MCE resistance.

Patient work of breathing is another parameter worthy of research via a balloon-fitted oesophageal probe. Our study evaluated absolute humidity and temperature using three different humidification devices. It would be useful to compare all available humidification devices currently on the market.

In Vitro Evaluation of an Active Heat-and-Moisture Exchanger:

The Hygrovent Gold

Paolo Pelosi MD, Paolo Severgnini MD, Gabriele Selmo MD, Michela Corradini MD, Maurizio Chiaranda MD, Raffaele Novario MP, and Gilbert R Park MD

BACKGROUND: To improve the heat and humidification that can be achieved with a heat-and- moisture exchanger (HME), a hybrid active (ie, adds heat and water) HME, the Hygrovent Gold, was developed. We evaluated in vitro the performance of the Hygrovent Gold. METHODS: We tested the Hygrovent Gold (with and without its supplemental heat and moisture options activated), the Hygrobac, and the Hygrovent S. We measured the absolute humidity, using a test lung venti- lated at minute volumes of 5, 10, and 15 L/min, in normothermic (expired temperature 34°C) and hypothermic (expired temperature 28°C) conditions. We also measured the HMEs’ flow resistance and weight after 24 h and 48 h. RESULTS: In its active mode the Hygrovent Gold provided the highest absolute humidity, independent of minute volume, in both normothermia and hypothermia.

The respective normothermia and hypothermia absolute humidity values at 10 L/min were 36.3 ⴞ 1.3 mg/L and 27.1 ⴞ 1.0 mg/L with the active Hygrovent Gold, 33.9 ⴞ 0.5 mg/L and 24.2ⴞ 0.8 mg/L with the passive Hygrovent Gold, 33.8 ⴞ 0.56 mg/L and 24.4 ⴞ 0.4 mg/L with the Hygrobac, and 33.9ⴞ 0.8 mg/L and 24.6 ⴞ 0.6 mg/L with the Hygrovent S. The efficiency of the tested HMEs did not change over time. At 24 h and 48 h the increase in weight and flow resistance was highest in the active Hygrovent Gold. CONCLUSIONS: The passive Hygrovent Gold provided adequate heat and moisture in normothermia, but the active Hygrovent Gold provided the highest humidity, in both normothermia and hypothermia. Key words: mechanical ventilation; humidifica- tion; humidity; heat-and-moisture exchanger; air flow resistance. [Respir Care 2010;55(4):460 – 466.

© 2010 Daedalus Enterprises]

Introduction

During normal breathing the upper airways heat and humidify inspired gas and thus prevent drying of the mu-

cosal membranes and other structures.¹Therefore, during invasive mechanical ventilation, when the upper airways are bypassed by an endotracheal tube, the inspired gas must be heated and humidified² to avoid damage to the respiratory epithelium, alterations in respiratory function, and heat loss.^3,4Conversely, animal studies (which used an ultrasonic nebulizer) showed that over-humidification can also cause injuries and alter respiratory function.^1,5In our opinion, an optimal humidification system has the fol- lowing properties: adequate heat and humidification, irre- spective of the ambient temperature, the patient’s temper- ature, or minute volume (V˙_E); the lowest possible dead space and flow resistance; no condensate; ease of use; low cost.

The 2 most commonly used types of humidification device are heated humidifier and heat-and-moisture ex- changer (HME).^6,7 Heated humidifier provides adequate humidity and temperature, and does not affect the breath- ing pattern, but can cause over-humidification at higher

Paolo Pelosi MD, Paolo Severgnini MD, Gabriele Selmo MD, Michela Corradini MD, and Maurizio Chiaranda MD are affiliated with the Di- partimento Ambiente, Salute, e Sicurezza; and Raffaele Novario MP is affiliated with the Dipartimento di Scienze Cliniche e Biologiche, Uni- versita` degli Studi dell’Insubria, Varese, Italy. Gilbert R Park MD is affiliated with the John Farman Intensive Care Unit, Addenbrooke’s Hospital, Cambridge, United Kingdom. Paolo Pelosi MD PhD is also affiliated with the Servizio di Anestesia B, Ospedale di Circolo e Fonda- zione Macchi, Varese, Italy.

Dr Severgnini has disclosed a relationship with Medisize, Hillegom, The Netherlands. The other authors have disclosed no conflicts of interest.

Correspondence: Paolo Pelosi MD, Servizio di Anestesia B, Ospedale di Circolo e Fondazione Macchi, viale Borri 57, 21100, Varese, Italy. E- mail: ppelosi@hotmail.com.

460 RESPIRATORY CARE• A^PRIL2010 VOL55 NO4

temperatures, and allow circuit condensation,^8,9which in- creases the risk of circuit bacterial colonization.^10,11Heated humidifiers are also expensive.

HMEs are efficient, avoid circuit condensate, and are less expensive.^12,13However, HME may not provide ade- quate heat and humidity during ventilation with large V˙_E,¹⁴ or when body temperature is low,¹⁵or when exhaled gas is lost.¹⁶ Furthermore, because HMEs increase respiratory work load, they should be used with caution in weak or tired patients with respiratory failure, during pressure-sup- port ventilation.^17,18 Nakagawa et al suggested that pa- tients with thick secretions should use the heated humid- ifier rather than HME.¹⁹

Recently, heated ventilator circuits were introduced.

They are efficient and do not produce condensate (and thus decrease the risk of bacterial contamination), but they are expensive and sometimes difficult to control to provide adequate heat and humidity with intubated patients.²⁰To overcome those limitations, a new active HME, the Hy- grovent Gold, was developed, which combines the sim- plicity of an HME with the features of an active humidi- fication system.

The Hygrovent Gold is similar to a common hygroscop- ic-hydrophobic HME, but it can also add heat and humid- ity to the inspired gas. The water is continuously added from an external source and wets the heated hygroscopic- hydrophobic membrane. We assessed in vitro the effi- ciency and stability over time of the Hygrovent Gold and 2 other commercially available HMEs.

Methods

We tested the Hygrovent Gold (Medisize, Hillegom, The Netherlands) with and without its supplemental heat and humidification system activated (ie, active Hygrovent Gold and passive Hygrovent Gold). We also studied the Hygrobac (Nellcor, Boulder, Colorado) and the Hygro- vent S (Medisize, Hillegom, The Netherlands). As reported by the manufacturer, the Hygrovent Gold (active or pas- sive) weighs 58 g and has an internal volume of 59 mL (catheter mount excluded). The Hygrobac and Hygro- vent S weigh 46.8 g and 34 g and have internal volumes of 92 mL and 55 mL, respectively. All the tested HMEs have microbiological retention greater than 99.99%.

The Hygrovent Gold’s active humidification system (Fig. 1) consists of an HME/filter with an adapter into which a heating element is inserted. The membrane in the Hygrovent Gold automatically regulates how much water passes through its calibrated porosity. The filter is con- structed of polycarbonate and has a hydrophobic mem- brane of polytetrafluoroethylene, polyester (Gore-tex), and aluminum. The heating element contains a temperature controller, powered by a 12-volt adapter, which prevents overheating. The heating element has a switch that ensures

that it works only when it is connected to the Hygrovent Gold. A light-emitting diode in the switch indicates when the heating element is functioning.

The Hygrovent Gold’s filter pore size is 0.2 ␮m. An aluminum grid inside the Hygrovent Gold protects the Gore-tex membrane from damage, heats the gas by acting as a thermal conductor, and detects the amount of gas passing through the filter and provides a feedback to the heater, which regulates the water evaporation output (⫾ 20% of the nominal water output, which is approxi- mately 3 mL/h). The aluminum grid is self-cleaning be- cause it has continuous steam output.

Experimental Protocol

The HMEs were tested in random order. Measurements were taken every 15 min, up to 1 h. Figure 2 shows the experimental setup.²⁰We connected a 2-L rubber bag with a plastic non-conducting tube to a ventilator (Evita 2, Dra¨ger, Lubeck, Germany) and a heated humidifier (MR730, Fisher & Paykel, Auckland, New Zealand) that heated and humidified the gas entering the humidifier, to mimic normothermic (34°C) and hypothermic (28°C) con- ditions. The temperature and humidity output of the lung model were checked before every measurement. We tested 3 V˙_E: 5, 10, and 15 L/min. We used volume-controlled ventilation, a tidal volume of 0.5 L, and 100% oxygen in all the tests. To stabilize the system before taking any measurements, we ventilated the model lung for 2 h with- out any HME.

With each HME we measured the flow resistance and weight at baseline and after 24 h and 48 h of continuous use at a V˙_Eof 10 L/min. To determine flow resistance we measured the pressure drop across the HME, at constant

Fig. 1. The Hygrovent Gold heat-and-moisture exchanger has an adapter into which a heating element is inserted, and a line that continuously supplies water.

INVITRO EVALUATION OF AN ACTIVEHEAT-AND-MOISTURE EXCHANGER: THE HYGROVENTGOLD

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flows of 0, 10, 20, 30, and 40 L/min. The gas flow rate was measured with a heated pneumotachograph (Fleish 2, Fleish, Lausanne, Switzerland) positioned next to the flow generator (Venturi, Starmed, Mirandola, Italy). The air- way pressure was measured with a pressure transducer (MPX 2010 DP, Motorola, Phoenix, Arizona) positioned across the HME. The ambient room temperature was 24 – 26°C. We measured the weight of the entire HME with a precision balance (PM100, Mettler Instrument, Hightstown, New Jersey). To standardize the weight measurements we measured the absolute change in weight at baseline, at 24 h, and at 48 h.

Hygrometric Measurements

We measured average temperature and absolute humid- ity during the inspiratory phase, with a psychrometric method. We placed the HME between the Y-piece of the ventilator circuit and the test lung. Between the HME and the lung model we inserted a device with 4 unidirectional valves to separate the inspiratory and expiratory gas flows.

The psychrometric method is the one most commonly used by clinicians to measure humidity²¹; it is based on 2 ther- mal probes: one dry and one wet.²² We used platinum flow-resistance thermometers (error range ⫾ 0.3°C, and no variation over time). The 2 probes were placed in the inspiratory side of the circuit, after the filter. Thus, the probe always had to measure the same amount of flow (ie, same velocity of air), without causing any measurement artifacts. Temperatures were measured electronically, dis- played and printed on a chart recorder (436004 uR1000, Yokogawa, Tokyo, Japan). The dry probe measures the gas temperature. The wet probe is coated with cotton that is wetted with sterile water, the evaporation of which is proportional to the dryness of the gas, so the temperature difference between the dry and wet probe is related to the gas humidity. To calibrate the 2 thermometer probes we inserted them in ice water to test their readings and read-

ing-difference at 0°C. The reading-difference was 0.1–

0.2°C. We then took readings in room air, and again the reading-difference was 0.1– 0.2°C, so we used that read- ing-difference value to correct the measurements obtained during the study. In each condition we computed the av- erage of 3 or 4 readings from the wet and dry probes.

Statistical Analysis

All data are expressed as mean ⫾ standard deviation.

We compared the data from the 4 HMEs (ie, the Hy- grobac, the Hygrovent S, the active Hygrovent Gold, and the passive Hygrovent Gold) with the Mann-Whitney test for independent samples and unpaired data.

Results

The temperature and absolute humidity of the expira- tory gas from the model lung were, respectively, 34.2 ⫾ 0.3°C and 39.9 ⫾ 0.6 mg H2O/L in the normo- thermic condition, and 28.1 ⫾ 0.4°C and 28.5

⫾ 0.5 mg H2O/L in the hypothermic condition, with no differences between the settings. This confirms the previ- ously reported good stability of this setup.²⁰

Normothermic Condition

The temperature and absolute humidity of the inspired gas significantly differed between the tested HMEs. In every normothermic test condition the active Hygrovent Gold had the highest temperature and absolute humidity (Fig. 3). With the active Hygrovent Gold, while tempera- ture was held constant, absolute humidity decreased lin- early with increasing V˙_E. The 3 passive HMEs increased temperature and absolute humidity at V˙_E values higher than 5 L/min.

Fig. 2. Experimental setup to test heat-and-moisture exchangers (HMEs).

INVITRO EVALUATION OF AN ACTIVEHEAT-AND-MOISTURE EXCHANGER: THE HYGROVENTGOLD

462 RESPIRATORY CARE• A^PRIL2010 VOL55 NO4

Hypothermic Condition

The active Hygrovent Gold also had the highest tem- perature and absolute humidity in the hypothermic test condition, at each V˙_E, but absolute humidity progressively decreased with increasing V˙_E. Increasing the V˙_Eincreased the temperature with all the HMEs, but the passive Hy- grovent Gold had a lower temperature at 5 L/min and 10 L/min. With the Hygrobac and Hygrovent S, absolute humidity was unaffected by increasing V˙_E. Conversely, compared to the other HMEs tested, with the passive Hy- grovent Gold, absolute humidity decreased at V˙_Eⱕ 15 L/

min. The temperature and absolute humidity with these 4 HMEs was not different at 24 h or 48 h.

Flow Resistance and Weight

Figure 4 shows the flow-resistance values at baseline, 24 h and 48 h. The flow resistance progressively increased

over time. At 24 h and 48 h the flow resistance was lowest with the Hygrobac, at all the tested flows. The weight- increase values with the active Hygrovent Gold, passive Hygrovent Gold, Hygrobac, and Hygrovent S were, re- spectively, 0.3⫾ ⬍ 0.1 g, 0.1 ⫾ ⬍ 0.1 g, 0.3 ⫾ ⬍ 0.1 g, and 0.1⫾ ⬍ 0.1 g at 24 h, and 7.7 ⫾ ⬍ 0.1 g, 4.6 ⫾ ⬍ 0.1 g, 1.1 ⫾ ⬍ 0.1 g, and 4.6 ⫾ ⬍ 0.1 g at 48 h. The active Hygrovent Gold had the highest weight increase, and the Hygrobac had the lowest.

Flow resistance at 40 L/min significantly correlated with the weight increase (r²⫽ 0.66, P ⬍ .002).

We found no condensate in the ventilator circuit with any of the HMEs tested.

Discussion

So far as we are aware, this is the first study of the efficiency of the Hygrovent Gold. The passive Hygrovent Gold, in the normothermic condition, provided heat and

Fig. 3. Mean⫾ SD temperature and absolute humidity, in normothermic and hypothermic conditions, at minute volumes of 5, 10, and 15 L/min, with 3 heat-and-moisture exchanger models: Hygrovent Gold (with and without its active humidification option), Hygrobac, and Hygrovent S. Between the devices: * P⬍ .001 versus passive Hygrovent Gold, Hygrobac, and Hygrovent S. ‡ P ⫽ .001 versus passive Hygrovent Gold and Hygrovent S.储 P ⫽ .001 versus Hygrobac and Hygrovent S. For a given device: † P ⫽ .001 versus 5 L/min. § P ⫽ .001 versus 15 L/min. Passive Hygrovent Gold (empty circles); active Hygrovent Gold (black circles); Hygrobac (empty squares); Hygrovent S (black squares).

INVITRO EVALUATION OF AN ACTIVEHEAT-AND-MOISTURE EXCHANGER: THE HYGROVENTGOLD

RESPIRATORY CARE• A^PRIL2010 VOL 55 NO4 463

humidity at least comparable to that of the other HMEs.

The active Hygrovent Gold’s heat and humidification were well above that of the passive HMEs, in both the normo- thermic and the hypothermic conditions. However, the ac- tive Hygrovent Gold’s increase in flow resistance and weight was higher than the other HMEs.

The optimal levels of heat and humidity remain debat- able.¹ Some have suggested an inspiratory absolute hu- midity of 44 mg H₂O/L, while others²have suggested an absolute humidity of 28 –35 mg H₂O/L. Two studies^23,24 found that an HME that delivered a mean absolute humid- ity of 30 mg H₂O/L could be safely used for up to 7 days in mechanically ventilated patients, which suggests that, in general, it is not necessary to provide an absolute humidity greater than 30 mg H₂O/L.

Passive Hygrovent Gold

In the normothermic condition the passive Hygrovent Gold provided an average absolute humidity of 33.9

⫾ 0.5 mg H2O/L, at 10 L/min, which had not changed at 48 h of continuous use, and was comparable to the other tested HMEs. We used the Hygrobac as a reference be- cause it has been reported to be one of the most efficient HMEs,²¹and the Hygrovent S to determine the influence of internal volume on HME efficiency.

In previous clinical investigations, a satisfactory abso- lute humidity (ie, ⱖ 30 mg H2O/L) was reported with HMEs at high V˙_E(10.5–16.5 L/min).²⁵In the present study

we found that a V˙_E of 5 L/min decreased the absolute humidity with all the tested HMEs, compared to 10 L/min and 15 L/min. Our data suggest that HME internal volume did not significantly affect the delivered heat and humidity in the normothermic condition, as the temperature and absolute humidity were similar between the Hygrovent S and the other HMEs.

As expected, the hypothermic condition markedly re- duced the humidity with all the HMEs. Although the pas- sive Hygrovent Gold had the lowest humidification at 15 L/

min, our data suggest that passive HMEs should be used with caution in moderately or severely hypothermic pa- tients.

Active Hygrovent Gold

In the normothermic condition the active Hygrovent Gold gave the highest humidification (absolute humidity 36.3 ⫾ 1.3 mg H2O/L at 10 L/min), at all the tested V˙_E. Although absolute humidity decreased with increasing V˙_E, it always remained in the recommended range.

Three other HME devices that have been reported are the Performer (StarMed, Mirandola, Italy), the Booster (TomTec, Kapellen, Belgium), and the Humid-Heat (Hud- son, Dardilly, France).

The Performer was a prototype that was never commer- cially available; it was used just for testing a new humid- ification concept. In the Performer the heating element was inserted between 2 cellulose membranes, whereas in

Fig. 4. Mean⫾ SD flow resistance at baseline, 24 h, and 48 h, at flows of 10, 20, 30, and 40 L/min, in 3 heat-and-moisture exchanger models: Hygrovent Gold (with and without its active humidification option), Hygrobac, and Hygrovent S. Between the devices: * P⫽ .001 versus baseline. † P⫽ .001 versus at 24 h.

INVITRO EVALUATION OF AN ACTIVEHEAT-AND-MOISTURE EXCHANGER: THE HYGROVENTGOLD

464 RESPIRATORY CARE• A^PRIL2010 VOL55 NO4

the Hygrovent Gold the heating element is apart from the membranes. And in the Performer, but not in Hygrovent Gold, the plate temperature could be individually set.

The Booster is a small electrically powered heating ele- ment that is placed between the HME and the patient. The element has a Gore-tex membrane on which water (added from the outside) vaporizes and humidifies the inspired gas.²⁶ The Hygrovent Gold represents an evolution of the Booster.

The main differences are that the Booster’s heating system and external water source are separate from the HME, and the Booster’s performance depends on the HME efficiency. In patients ventilated with the Booster for 96 h, the inspired gas temperature and absolute humidity were higher (2–3°C and 2–3 mg H₂O/L) than with a standard HME, and there was no bacterial colonization of the ventilator circuit.²⁶

The Humid-Heat, which adds water and heat on the patient side of the HME circuit, can boost temperature and absolute humidity up to 37°C and 44 mg H₂O/L, which are close to the temperature and humidity with a conventional heated humidifier.^9,27,28

With all the above devices, if the water supply runs out, the HME continues to work as passive HME, which avoids the risk that dry gas will be delivered to the patient.

The Hygrovent Gold is a commercially available hybrid active/passive humidification system, intended to replace the Booster, so it is important to evaluate the performance of the Hygrovent Gold in vitro in various experimental conditions.

It is usually recommended not to use a passive HME when the patient’s core temperature and, consequently, expired ab- solute humidity are low, and to use HME cautiously in pa- tients with thick secretions.¹ On the other hand, during hy- pothermia, with the currently recommended settings, heated humidifier carries the risk of over-humidification and harm- ful effects on respiratory mechanics (micro-atelectasis, de- crease in lung compliance, and surfactant impairment), in addition to other problems related to HMEs. In the hypother- mic condition we found that the active Hygrovent Gold was more efficient than the passive HMEs. The difference be- tween the absolute humidity delivered from the HME and the expired humidity was 0.6 mg H₂O/L at 5 L/min, 1.5 mg H₂O/L at 10 L/min, and 1.8 mg H₂O/L at 15 L/min. This indicates that, within the V˙_E range we tested, the active Hygrovent Gold maintained a balance between the inspiratory and ex- piratory absolute humidity.

However, the fact that temperature increases while ab- solute humidity decreases with the Hygrovent Gold sug- gests that the Hygrovent Gold has a fixed moisture output that is not able to adapt to changing V˙_E. Furthermore, the lower V˙_Eresulted in lower moisture output. This can be related to cooling of the device during a prolonged expi- ratory time, and to a smaller expired volume reaching the HME during expiration. In agreement with our results, Lellouche and co-workers reported more physiologic heat-

ing and humidification in hypothermic patients with the Humid-Heat than with conventional passive HME or heated humidifier.²⁹However, heated humidifier may be prefer- able in the presence of extreme hypothermia.

Flow Resistance and Dead Space

The presence of any HME in the circuit increases flow resistance and dead space.³⁰ We found that among the passive HMEs the Hygrobac had the least flow-resistance increase over time, and the active Hygrovent Gold had the most. However, the flow resistance increased with all the HMEs after 48 h. That the active Hygrovent Gold had the greater flow-resistance increase is probably due to accu- mulation of water in the device, as indicated by the weight increase. This might suggest that the active Hygrovent Gold should not be used for over 24 h. Although the added flow resistance is less than that from an endotracheal tube, the flow resistance may be additive in the breathing circuit and might increase the work of breathing and air-trapping, especially during assisted ventilation.¹⁸Because the inter- nal volume of the Hygrovent Gold is less than that of the Hygrobac (59 mL vs 92 mL), its possible negative effect on respiratory function during controlled³¹ or assisted¹⁸ ventilation should be minimized. However, HME should be cautiously used in patients who are difficult to wean, unless the level of ventilatory assistance is increased.¹⁷ Limitations

First, we did not examine in vivo the effects of the tested HMEs on respiratory function, secretions, or micro- biological contamination of the ventilator circuit, so our data apply only to our specific experimental conditions, and should be tested in a clinical setting. Second, we com- pared the Hygrovent Gold to only 2 other brands of pas- sive HMEs. However, the Hygrobac, which was included in the study, has been reported as one of the most efficient available HMEs. Third, we did not compare Hygrovent Gold to other hybrid active/passive HMEs. Fourth, a com- parison with heated humidifier could have been interest- ing, but a previous study²⁰found that the absolute humid- ity range from a heated humidifier was 37– 40 mg H₂O/L at 5 L/min and 39 – 47 mg H₂O/L at 15 L/min, at 35°C and 39°C, respectively. We found lower absolute humidity with Hygrovent Gold than with heated humidifier. Fifth, we only made flow-resistance measurements at flows up to 40 L/min, because that value represents the average in- spiratory flow usually reached during conventional me- chanical ventilation. Sixth, we did not evaluate cost and economic issues. Although most HMEs are relatively in- expensive, daily changing of the HME would increase the cost of humidification.

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Conclusions

Although HMEs can be safely used during long-term ventilation,^23,24many centers do not routinely use HME, for fear of obstruction and insufficient humidification.³² Because the active Hygrovent Gold can deliver higher temperature and absolute humidity, it may be useful in patients in whom passive HME appears to worsen the clinical characteristics of secretions, and in hypothermic patients who would otherwise require heated humidifier.

As compared to conventional HMEs, the passive Hygrovent Gold provided adequate heat and humidification during nor- mothermia, but the active Hygrovent Gold provides higher humidification in both normothermia and hypothermia.

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A novel method of evaluation of three heat-moisture exchangers in six different ventilator settings. Intensive Care Med 1998;24(2):138-146.

15. Roustan JP, Kienlen J, Aubas P, Aubas S, du Cailar J. Comparison of hydrophobic heat and moisture exchangers with heated humidifier during prolonged mechanical ventilation. Intensive Care Med 1992;

18(2):97-100.

16. Rathgeber J. Devices used to humidify respired gases. Respir Care Clin N Am 2006;12(2):165-182.

17. Girault C, Breton L, Richard JC, Tamion F, Vandelet P, Aboab J, et al. Mechanical effects of airway humidification devices in difficult to wean patients. Crit Care Med 2003;31(5):1306-1311.

18. Pelosi P, Solca M, Ravagnan I, Tubiolo D, Ferrario L, Gattinoni L.

Effects of heat and moisture exchangers on minute ventilation, ventila- tory drive, and work of breathing during pressure-support ventilation in acute respiratory failure. Crit Care Med 1996;24(7):1184-1188.

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24. Djedaini K, Billiard M, Mier L, Le Bourdelles G, Brun P, Marko- wicz P, et al. Changing heat and moisture exchangers every 48 hours rather than 24 hours does not affect their efficacy and the incidence of nosocomial pneumonia. Am J Respir Crit Care Med 1995;152(5 Pt 1):1562-1569.

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26. Thomachot L, Viviand X, Boyadjiev I, Vialet R, Martin C. The combination of a heat and moisture exchanger and a Booster: a clinical and bacteriological evaluation over 96 h. Intensive Care Med 2002;28(2):147-153.

27. Branson RD, Campbell R, Johannigman JA, Ottaway M, Davis K, Luchette F, et al. Comparison of conventional heated humidification with a new active hygroscopic heat and moisture exchanger in me- chanically ventilated patients. Respir Care 1999;44(8):912-917.

28. Kapadia F, Shelly MP, Anthony JM, Park GR. An active heat and moisture exchanger. Br J Anaesth 1992;69(6):640-642.

29. Lellouche F, Qader S, Taille S, Lyazidi A, Brochard L. Under-humid- ification and over-humidification during moderate induced hypothermia with usual devices. Intensive Care Med 2006;32(7):1014-1021.

30. Chiaranda M, Verona L, Pinamonti O, Dominioni L, Minoja G, Conti G. Use of heat and moisture exchanging (HME) filters in mechanically ventilated ICU patients: influence on airway flow-re- sistance. Intensive Care Med 1993;19(8):462-466.

31. Prat G, Renault A, Tonnelier JM, Goetghebeur D, Oger E, Boles JM, et al. Influence of the humidification device during acute respiratory distress syndrome. Intensive Care Med 2003;29(12):2211-2215.

32. Ricard JD, Cook D, Griffith L, Brochard L, Dreyfuss D. Physicians’

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DEKRA Certification B.V.

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e

ing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

EC CERTIFICATE

Number: 2077698CE01

Full Quality Assurance System

Directive 93/42/EEC on Medical devices, Annex II excluding (4)

(Devices in Class IIa, IIb or III)

Manufacturer:

Medisize B.V.

Hoeksteen 72b 2132 MS Hoofddorp The Netherlands

For the product category(ies)

Respiratory management devices and accessories

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical

Documentation and meeting the provisions of the EC-Directive which apply to them:

0344

Documents, that form the basis of this certificate:

Certification Notice 2077698CN, initially dated 8 January 2014 Addendum, initially dated 17 October 2004

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medical devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system for design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance. For placing on the market of Class III devices an additional EC design examination certificate according to Annex II (4) is mandatory.

The necessary information related to the quality management system of the manufacturer, including facilities and the reference to the relevant documentation, of the products concerned and the assessments performed, are stated in the Certification Notice which forms an integrative part of this certificate.

This certificate is valid until: 1 August 2023 Issued for the first time: 17 October 2004

Reissued: 1 August 2018

ADDENDUM

Belonging to certificate: 2077698CE01 1/1

CE MARKING OF CONFORMITY

MEDICAL DEVICES

Respiratory management devices and accessories Issued to:

Medisize B.V.

Hoeksteen 72b 2132 MS Hoofddorp The Netherlands

DEKRA Certification B.V.

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e

ing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

This certificate covers the following product(s):

- Non-active respiratory and anaesthetic breathing devices - Breathing devices

- Humidifiers

Initial date: 17 October 2004 Revision date: 3 October 2007

DEKRA Certification B.V.

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e

ing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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Number: 2077698CE03

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Directive 93/42/EEC on Medical devices, Annex V

(Devices in Class I in sterile conditions and sterilised systems or procedure packs)

Manufacturer:

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For the product category(ies)

sterile medical disposables and sets

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical

Documentation and meeting the provisions of the EC-Directive which apply to them:

0344

Documents, that form the basis of this certificate:

Certification Notice 2077698CN, initially dated 8 January 2014

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medical devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system, that covers the aspects of manufacture concerned with securing and maintaining sterile conditions, for the above

mentioned product category in accordance to the provisions of Annex V Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance.

The necessary information related to the quality assurance system of the manufacturer, including facilities and the reference to the relevant documentation, of the products concerned and the assessments performed, are stated in the Certification Notice which forms an integrative part of this certificate.

This certificate is valid until: 1 August 2023 Issued for the first time: 17 October 2004

Reissued: 1 August 2018

DEKRA Certification B.V.

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e

ing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

EC CERTIFICATE

Number: 2160644CE01

Production Quality Assurance

Directive 93/42/EEC on Medical devices, Annex V

(Devices in Class IIa, IIb or III)

Manufacturer:

Medisize B.V.

Hoeksteen 72b 2132 MS Hoofddorp The Netherlands

For the product category(ies)

Maximalsystem; sterile and non-sterile breathing circuits and related accessories

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical

Documentation and meeting the provisions of the EC-Directive which apply to them:

0344

Documents, that form the basis of this certificate:

Certification Notice 2160644CN, initially dated 8 January 2014

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medical devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system for the manufacture and final inspection for the above mentioned product category in accordance to the provisions of Annex V of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance. For placing on the market of Class III or Class IIb devices an additional EC type-examination certificate according to Annex III is mandatory.

The necessary information related to the quality assurance system of the manufacturer, including facilities and the reference to the relevant documentation, of the products concerned and the assessments performed, are stated in the Certification Notice which forms an integrative part of this certificate.

This certificate is valid until: 1 August 2023 Issued for the first time: 20 May 2013

Reissued: 1 August 2018

DEKRA Certification B.V.

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drs. G.J. Zoetbrood

e

ing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

CERTIFICATE

Number: 2160644

The management system of:

Medisize B.V.

Hoeksteen 72b 2132 MS Hoofddorp The Netherlands

including the implementation meets the requirements of the standard:

ISO 13485:2016

Scope:

Design and development, manufacture and distribution of airway management systems, sterile and non- sterile medical disposables and sets for use in transfusion/infusion/drainage/suction systems.

Certificate expiry date: 1 August 2021 Certificate effective date: 1 August 2018 Certified since: 1 August 2015