ISO 4135:2022 麻酔および呼吸装置 — 語彙 | ページ 6

3.1.1.1

絶対湿度

気体の単位体積中に存在する水蒸気の質量

注記 1:呼吸用途では、絶対湿度は一般に 1 リットルあたりのミリグラムまたは 1 立方メートルあたりのグラムの単位で表され、体積は BPTS 条件で表されます。

注記2 相対湿度（3.1.2.4） も参照のこと。

3.1.1.2

断熱圧縮

システム内外への熱の移動なしに発生する圧縮プロセス

3.1.1.3

エアロゾル

気体中の液体または固体粒子の懸濁液

3.1.1.4

手術器具を駆動するための空気

ガスの天然または合成混合物で、主に指定された割合の酸素と窒素で構成され、汚染物質の濃度の制限が定義されており、手術器具の電源として機能することを目的としています。

3.1.1.5

麻酔ガス

揮発性麻酔薬の蒸気、または麻酔に使用されるガスの混合物である可能性があるガス

注記 1 麻酔呼吸システム (3.6.1.8) の一部には，患者が吐き出す麻酔ガスが含まれる。

3.1.1.6

自動発火温度

特定の条件下で物質が自然発火する温度

3.1.1.7

体温と圧力が飽和

BTPS

周囲大気圧、温度 37 °C, 相対湿度 (3.1.2.4) 100%

3.1.1.8

常温常圧乾燥

STPD

20 °C の温度で 101.325 kPa の圧力、乾燥

3.1.1.9

キャリアガス

<呼吸器療法>物質を患者に運ぶ呼吸ガス

3.1.1.10

キャリアガス

<anaesthesia> 1 つまたは複数の 麻酔ガス (3.1.1.5) を患者に運ぶ呼吸ガス。

3.1.1.11

燃焼

熱と光を生成するための急速な酸化

3.1.1.12

コンプライアンス

密閉空間内の単位圧力変化あたりの気体の体積変化

注記 1:適合性の定義に測定条件を含めることは推奨されません。一般に、コンプライアンスは、指定された測定条件で表すことができます。

注記 2: ISO 19223 は、肺コンプライアンス、呼吸器系コンプライアンス、静的コンプライアンス、動的コンプライアンスの定義を提供しており、これらはすべて患者に関連しています。呼吸チューブ(3.1.4.4) やリザーバー バッグなどの機器の項目に関して、ISO/TC 121 参照コンプライアンスからの他のさまざまな規格。

3.1.1.13

供給ガス温度

患者接続ポート（3.1.4.41） を基準とした、患者に送達されるガス、 エアロゾル（3.1.1.3） 、またはその両方の温度。

3.1.1.14

送達酸素濃度

指定された場所に供給されるガス中の酸素濃度

3.1.1.15

_FiO2

吸気酸素の割合

患者が吸入したガス中の酸素濃度

注記1:FiO ₂の測定部位は、機器の製造業者によって指定されるべきであるが、吸気を意図したガス中の酸素濃度を参照すべきである。

3.1.1.16

フレッシュガス

呼吸システム（3.6.1.1） に送られる呼吸に適したガス。

注記 1: 循環式呼吸システム (3.6.1.8.1) では、フレッシュガスは、循環式呼吸システムに供給されるすべての呼吸に適したガス ( 麻酔ガス (3.1.1.5) および蒸気を含む) です。これには、 酸素 (3.1.1.21) または 麻酔気化器に供給される空気 (3.3.2.2) が含まれる場合があり、麻酔気化器によって生成される蒸気が含まれる場合もあります。

注記 2:開放型 呼吸システム (3.6.1.1) では、フレッシュガスはすべて、呼吸システム(呼吸システム内の任意の場所にあってもよい) に供給される呼吸可能なガスです。

3.1.1.17

医療用ガス

薬理学的、免疫学的、または代謝作用を発揮することによって生理学的機能を回復、修正、または変更する目的で、または医学的診断を行う目的で使用できるガスまたはガスの混合物。

3.1.1.18

医療用空気

天然ガスまたは合成ガスの混合物で、主に指定された割合の酸素と窒素から構成され、汚染物質の濃度の制限が定義されており、患者への投与を目的としています。

3.1.1.19

医療機器ガス

メーカーが医療機器または医療機器の付属品として使用することを意図したガスまたはガスの混合物

注記1: これには，解剖学的構造または生理学的過程の調査または改変のための使用が含まれ，人体の内部または表面で，薬理学的，免疫学的または代謝的手段による主要な意図された作用を達成しないが，補助される可能性があるそのような手段によってその機能において。

注記 2:国によっては、医療機器のガスが医療機器または医薬品として規制されているか、規制の対象になっていない場合があります。

3.1.1.20

医療ガス

麻酔、治療、診断または予防の目的で患者に投与することを目的としたガスまたはガスの混合物、または医療または手術ツールの空気圧源として

3.1.1.21

空気

医療用ガス（3.1.1.17）。 酸素濃度はwhere 関連する薬局方のモノグラフで指定された最小値以上です。

3.1.1.22

酸素 93

非推奨:酸素が豊富な空気

酸素濃度が少なくとも関連する薬局方の酸素に関するモノグラフで指定された最小値でwhere 医療用ガス (3.1.1.17) 93

注記1:酸素93は通常、圧力スイング吸着 酸素濃縮器(3.2.1.3.7) によって医療提供者のサイトで製造される。

3.1.1.23

分圧

ガス混合物中の各ガスが、同じ温度で混合物の体積を単独で占める場合に及ぼす圧力

3.1.1.24

飽和蒸気圧

気化と凝縮の間の動的平衡に達したときの液体と気体の界面における特定の温度での蒸気の 分圧（3.1.1.23）

3.1.1.25

吸引

液体、固体粒子、 エアロゾル（3.1.1.3） またはガスを除去するための 真空（3.1.1.27） の適用

3.1.1.26

熱伝導率

面積に垂直な方向の、単位温度勾配あたりの単位面積を通る熱流量。

3.1.1.27

真空

周囲圧力未満の圧力

3.1.1.28

体積分率

体積パーセント

混合物中の気体の体積で、総体積の割合として表される

注記1：体積分率は、パーセンテージまたは分数として表すことができます。

注記2同義語の体積パーセントは、体積分率をパーセンテージで表現するために予約されています。

3.1.2.1

アクセス可能な表面温度

臨床使用中に発生するメンテナンス作業中を含む、通常の使用中に人体の任意の部分と接触する可能性があるデバイスの表面の温度

注記1: メンテナンス作業には、リザーバーに水または薬剤を補充することが含まれます。清掃と除染;そして電池交換。

3.1.2.2

帯電防止

静電荷の蓄積を分散または阻害する材料または手順の特性

3.1.2.3

ガス固有

異なるガスサービス、 真空（3.1.1.27） サービスおよび 麻酔ガス掃気システム（3.9.1.1） 間の接続を妨げる特性を持つ。

注記1：ターミナルユニット（3.2.2.1）、シリンダー 出口（3.1.4.40） 、 低圧ホースアセンブリ（3.2.3.1） 、および機器ガス 入口（3.1.4.26） および出口（3.1.4.40）は例ですガスサービスの。

3.1.2.4

相対湿度

特定の温度における 飽和蒸気圧 (3.1.1.24) のパーセンテージとして表される水蒸気圧

注記1： 絶対湿度（3.1.1.1） も参照のこと。

3.2.1.1

医療用ガスパイプラインシステム

医療用ガス（3.1.1.20 ） or 真空（3.1.1.27） を提供するための 供給システム（3.2.1.2） 、監視および警報システム、および パイプライン分配システム（3.2.1.6 ）と端末ユニット（3.2.2.1） の組み合わせ。

3.2.1.2

供給システム

医療ガス供給システム

医療用ガス（3.1.1.20） を パイプライン分配システム（3.2.1.6） に供給する 1 つまたは複数 の供給源（ 3.2.1.3）の組み合わせ

3.2.1.3

供給元

パイプライン 分配システム（3.2.1.6） に供給する関連 制御装置（3.2.1.5） を備えた 供給システム（3.2.1.2） の部分。

3.2.1.3.1

一次供給元

パイプライン 分配システム（3.2.1.6）に 供給するために最初に引き出される供給 システム（3.2.1.2） の部分。

3.2.1.3.2

二次供給元

一次供給源（3.2.1.3.1） が枯渇または故障した場合に パイプライン分配システム（3.2.1.6）に 供給する 供給システム（3.2.1.2） の部分。

3.2.1.3.3

予備供給元

一 次供給源（3.2.1.3.1）の 両方が故障又は枯渇した場合に ，パイプライン分配システム（3.2.1.6） の全部又は一部を供給する 供給システム（3.2.1.2） の部分。 ） および 二次供給源（3.2.1.3.2）

3.2.1.3.4

低温液体システム

−150℃未満の温度で容器内に液体状態で貯蔵されたガスを含む 供給システム（3.2.1.2）。

3.2.1.3.5

非極低温液体システム

−150℃以上の温度で圧力下で容器内に液体状態で貯蔵されたガスを含む 供給システム（3.2.1.2）。

3.2.1.3.6

空気圧縮機システム

医療用空気（3.1.1.18） or 外科用駆動器具（3.1.1.4）用の空気 を供給するように設計されたコンプレッサーを備えた 供給システム（3.2.1.2）。

3.2.1.3.6.1

ブースターコンプレッサー

高圧を高圧に上げるために使用されるコンプレッサー

3.2.1.3.7

酸素濃縮器

窒素の抽出によって周囲空気から 酸素93（3.1.1.22） を生成する 供給源（3.2.1.3） の成分。

3.2.1.3.7.1

膜酸素濃縮器

酸素濃縮器(3.2.1.3.7) 膜を介した酸素の選択的透過によって機能する。

3.2.1.3.7.2

圧力スイング吸着装置

PPE

モレキュラーシーブ装置

酸素濃縮器（3.2.1.3.7）。 酸素濃縮器（3.2.1.3.7）。モレキュラーシーブ材料の床を通る周囲空気の交互の加圧と通過中に、窒素の選択的な保持とパージによって機能する。

3.2.1.3.8

比例単位

ガスが一定の比率で混合される 供給源（3.2.1.3） の構成要素。

3.2.1.3.9

非常用入口

非常用電源（3.2.1.3.10）の接続を可能にする パイプライン分配システム（3.2.1.6） 内の 入口 （3.1.4.26） ポイント。

3.2.1.3.10

緊急供給

供給源（3.2.1.3）は、 パイプライン分配システム（3.2.1.6） 内の 非常入口（3.2.1.3.9） に接続することを意図しています。

3.2.1.3.11

メンテナンス補給口

非推奨:メンテナンス サプライ アセンブリ

メンテナンス サプライ (3.2.1.3.12) の接続を可能にする インレット (3.1.4.26)

3.2.1.3.12

メンテナンス用品

メンテナンス中にシステムに供給することを意図した 供給元（3.2.1.3）

3.2.1.3.13

供給圧力調整器

供給源（3.2.1.3 ）内に取り付けられ，ライン圧力調整器（3.2.1.6.2）に供給される圧力を調整することを意図した 圧力調整器 （3.2.4.1）。

3.2.1.4

真空源

大気圧未満の流れを提供するように設計されたポンプを含む 供給源（3.2.1.3） の構成要素。

注記 1: 真空 (3.1.1.27) も参照のこと。

3.2.1.5

制御機器

医療用ガス（3.1.1.20） 供給システム（3.2.1.2）を 指定された動作パラメータ内に維持するために必要なアイテム

3.2.1.6

パイプライン分配システム

供給源（3.2.1.3） を ターミナルユニット（3.2.2.1） に接続する 医療用ガスパイプラインシステム（3.2.1.1） の一部。

3.2.1.6.1

二段パイプライン分配システム

パイプライン分配システム（3.2.1.6） では、ガスは最初に 供給システム（3.2.1.2） から 公称分配圧力（3.2.1.11） よりも高い圧力で分配され、その後 公称分配圧力（3.2.1.11）に下げられます。 1.11) ライン圧力調整器による (3.2.1.6.2)

3.2.1.6.2

ライン圧力調整器

公称供給システム （3.2.1.2） の圧力を公称分配圧力 （3.2.1.11） に下げるために、二段パイプライン分配システム（3.2.1.6.1）で使用される圧力調整器 （3.2.4.1）。

3.2.1.6.3

パイプライン ブランチ

施設の同じ階の 1 つ以上のエリアに供給する パイプライン分配システム (3.2.1.6) の部分。

3.2.1.6.4

シャットオフバルブ

遮断弁

ゾーンバルブ

閉じたときに両方向の流れを防ぐバルブ

3.2.1.6.5

単段パイプライン分配システム

公称 分配圧力（3.2.1.11） でガスが 供給システム（3.2.1.2） から分配されるパイプ ライン分配システム（3.2.1.6）。

3.2.1.7

試運転

合意されたシステム仕様が満たされ、責任ある組織によって受け入れられていることを検証するための機能証明

3.2.1.8

多様性係数

医療施設の管理（3.1.6.6） と合意して定義された流量で、同時に使用される定義された臨床領域内の 端末ユニット（3.2.2.1） の最大割合を表す係数。

3.2.1.9

最大分配圧力

医療ガス (3.1.1.20) パイプライン分配システム (3.2.1.6) が ゼロ流量で動作している場合の ターミナル ユニット (3.2.2.1) の圧力

3.2.1.10

最小分配圧力

医療ガス (3.1.1.20) パイプライン分配システム (3.2.1.6) が システム設計フロー (3.2.1.12) で動作している場合、任意の ターミナル ユニット (3.2.2.1) での最低圧力

3.2.1.11

公称分配圧力

供給システム（3.2.1.2） が ターミナルユニット（3.2.2.1） に供給しようとしている圧力

3.2.1.12

システム設計の流れ

医療施設の最大流量要件 (3.1.6.6) から計算され、 多様性係数 (3.2.1.8) によって補正された流量

3.3.1.1

麻酔器

医療用ガス（3.1.1.20） 、 麻酔ガス（3.1.1.5） 、および蒸気を 呼吸システム（3.6.1.1） に分配および送達するための装置。

3.3.1.2

麻酔ワークステーション

麻酔ガス供給システム（3.3.2.1） 、 麻酔呼吸システム（3.6.1.8） 、および必要な 監視機器（3.11.1.3） 、警報システム、および 保護装置（3.1.4.48）を 含む吸入麻酔を管理するためのシステム。

注記 1麻酔ワークステーション に は 、 以下の 1 つ または 複数を含めることもできますが、これらに限定されません。 システム（3.9.1.1） 、および関連する 監視機器（3.11.1.3） 、警報システムおよび保護装置（3.1.4.48）。

3.3.1.3

最小肺胞濃度

マック

吸入麻酔薬の肺胞濃度で、他の麻酔薬が存在しない状態で平衡状態にある場合、被験者の 50% が標準的な外科的刺激に反応して動くのを防ぐ

注記 1この国際規格の目的のために， MAC は呼気終末 ガスレベルから計算される (3.11.2.6) 。

3.5.1.1

携帯用液体酸素システム

酸素療法（3.1.5.9） 用の 1 つまたは複数の 液体酸素ポータブル ユニット（3.5.1.3 ）および互換性のある液体酸素ベース ユニット（3.5.1.2） を含むシステム

3.5.1.2

液体酸素ベースユニット

酸素（3.1.1.21） を貯蔵し、 液体酸素ポータブルユニット（3.5.1.3） を補充する目的でそれを液体状態に維持することを目的とした真空断熱極低温容器であり、内部気化器と患者への気体酸素の直接供給のための流量制御

3.5.1.3

液体酸素ポータブルユニット

液体酸素を極低温に維持するための真空断熱極低温容器、内部気化器、およびガス状酸素を患者に提供するためのフロー制御を含む携帯型装置

3.5.1.4

液体酸素移送コネクタ

コネクタ（3.1.4.5）は、 液体酸素ベースユニット（3.5.1.2） から 液体酸素携帯ユニット（3.5.1.3） に液体酸素を移送するため、または液体酸素ベースユニットを補充するために使用されます

3.6.1.1

呼吸システム

人工呼吸器（3.4.1.2）または呼吸療法のいずれかの形態において、呼吸圧s （3.6.1.2） で患者に、または患者からガスが流れ、患者の気道と連続的または間欠的に流体連通する経路。

注記2：呼吸システムは通常、ガス混合物が大気または 麻酔ガス除去システム（3.9.1.1） に逃げるポイントまで、例えば APLバルブ（3.6.3.5） またはティー。

注記3:呼吸システムのコンポーネントの配置と使用方法は、吸気混合ガスの組成に影響を与えます。

注記 4: 麻酔ガス除去システム (3.9.1.1) のみに関係するガス経路は、呼吸システムの一部とは見なされません。

注記5呼吸システムという用語の定義におけるあいまいさをすべて排除することはできない。この用語が規格や文書、またはその正確な解釈に影響を与える可能性のあるその他の科学出版物で使用されている場合、そこで言及されている呼吸システムの制限と構成を明確に定義する必要があります。

3.6.1.2

呼吸圧

任意の形態の 人工換気（3.4.1.2） または自発呼吸中に患者の気道（3.8.1.1）と連通するガスの圧力。

注記 1: 気道内圧 (3.1.4.41.1) は、 人工呼吸器呼吸システム (3.4.1.9) の 患者接続ポート (3.1.4.41) でのガス圧に対する特定の基準です。

3.6.1.3

麻酔リザーバーバッグ

麻酔 呼吸システム（3.6.1.8） の構成要素である折り畳み式ガス容器。

3.6.1.3.1

バッグ入口弁

人工呼吸器（3.4.1.8 ）の圧縮ユニット（ 3.4.1.11）内の減圧によって作動し，圧縮ユニットに大気圧のガスを補充する弁。

3.6.1.3.2

バッグ詰め替えバルブ

人工呼吸器（3.4.1.8 ）の圧縮ユニット（ 3.4.1.11）内の減圧によって作動し、加圧ガス源から圧縮ユニットを補充する、手動トリガーのないバルブ。

3.6.1.4

呼吸アタッチメント

呼吸システム（3.6.1.1） の一部を形成することを目的とした、 ユーザーが取り外し可能な（3.1.4.38） コンポーネント。

3.6.1.5

呼吸システムフィルター

BSF

呼吸システム（3.6.1.1） における微生物を含む微粒子の透過を減少させることを意図した装置。

3.6.1.6

呼吸セット

呼吸チューブ（3.1.4.4） 、 コネクタ（3.1.4.5）、 および麻酔呼吸システム（3.6.1.8） or 人工呼吸器呼吸システム（3.4.1.9） のガス経路の吸気および呼気肢を形成するコンポーネントのアセンブリ。 人工呼吸器 (3.4.1.1) および患者の 気道確保器具 (3.8.1.2)

3.6.1.7

フレッシュガス供給チューブ

新鮮ガス（3.1.1.16）を 麻酔呼吸システム（3.6.1.8） の 新鮮ガス入口（3.1.4.20） に運ぶチューブ

3.6.1.8

麻酔呼吸システム

揮発性又はガス状の麻酔薬と共に使用することを意図した 呼吸システム（3.6.1.1）。

3.6.1.8.1

サークル呼吸システム

麻酔サークル呼吸システム

吸気経路と呼気経路を通るガスの流れの方向が一方向であり，2 つの経路がループを形成する 呼吸システム（3.6.1.1）。

注記 1:麻酔の文脈では、 呼吸システム (3.6.1.1) は 循環呼吸システムであることが多い。

3.6.1.8.2

サークルアブソーバーアッセンブリー

1つまたは複数の二酸化炭素吸収容器、 吸気弁（3.6.3.1） および 呼気弁（3.6.3.2） または一方向のガスの流れを確保するその他の手段を含む 循環呼吸システム（3.6.1.8.1） の一部、2つ呼吸 チューブ（3.1.4.4） 、 フレッシュガス入口（3.1.4.20） 、リザーバーバッグポートまたは 麻酔人工呼吸器（3.4.1.3） ポート、またはその両方に接続するためのポート（3.1.4.10）

3.6.1.9

空気巻き込み装置

1つ以上の空気連行 ポート（3.1.4.10） に隣接するジェットオリフィスからなる装置。

3.7.1.1

熱的危険

火災、過剰な表面温度または過剰な 供給ガス温度による危険 (3.1.1.13)

3.7.1.2

温度オーバーシュート

電力の減少または停止またはガス流量の変化に続く、 供給ガス温度（3.1.1.13） の一時的な上昇。

3.9.1.1

麻酔ガス除去システム

AGSS

過剰な 麻酔ガス（3.1.1.5 ）及び蒸気を適切な排出点に運ぶ目的で ，呼吸システム（3.6.1.1） 又は他の装置の排気ポート（3.1.4.11）に接続されたシステム。

注記 機能的には， AGSS は， 移送システム（3.9.1.3.5） ， 受信システム（3.9.1.3.4） 及び AGSS 廃棄システム（3.9.1.3）の 3 つの部分から構成される。これらの 3 つの機能的に個別の部分は、個別に、または部分的または全体的に連続して組み合わせることができます。 AGSSの 1 つ以上の部品は、麻酔 呼吸システム (3.6.1.8) コンポーネントまたは他の機器と組み合わせることができます。

3.9.1.2

アクティブ麻酔ガス掃気システム

アクティブAGSS

AGSS 廃棄 システム（3.9.1.3） 内のガス流が AGSS 電源装置（3.9.1.3.12）から生じる麻酔ガス掃気システム（3.9.1.1） 。

注記 1アクティブ AGSSでは、ガス流は、受入システム ( 3.9.1.3.4) の減圧によって引き起こされます。 医療用ガスパイプラインシステム（3.2.1.1） （タイプ 1 ターミナルユニット（3.9.1.3.13） 付き）またはタイプ 2 ターミナルユニット（3.9.1.3 ）に接続するための麻酔ガス掃気システム（ 3.9.1.1）のコンポーネント .14) .

3.9.1.3

AGSS処理システム

排気ガス を受容システム（3.9.1.3.4） から排出ポイントまで搬送する麻酔ガス 掃気システム（3.9.1.1） の一部。

注記1: 放出点は、例えば、建物の外部または非再循環抽出換気システムである可能性があります。

3.9.1.3.1

廃棄ホース

排出ガス を受入システム（3.9.1.3.4） から AGSS廃棄システム（3.9.1.3） に運ぶフレキシブルチューブ。

3.9.1.3.2

第一種廃棄ホース

真空（3.1.1.27） 源に接続するための 廃棄ホース（3.9.1.3.1）

注記1：これはISO 7396-2で受信ホースに指定されています。第 1 種廃棄ホースと 第 2 種廃棄ホースの用語の提案 (3.9.1.3.3) は、使用の不一致に対処するために行われます。 ISO 80601-2-13, ISO 7396-2, および ISO 9170-2 も参照してください。

3.9.1.3.3

第二種廃棄ホース

陽圧で作動することを意図した 廃棄ホース（3.9.1.3.1）。

注記 1：これは、ISO 7396-2 で 廃棄ホース (3.9.1.3.1) として指定されています。 タイプ 1 廃棄ホース (3.9.1.3.2) とタイプ 2 廃棄ホースの用語の提案は、使用の不一致に対処するために行われます。 ISO 80601-2-13, ISO 7396-2, および ISO 9170-2 も参照してください。

3.9.1.3.4

受信システム

ガスを 呼吸システム（3.6.1.1） のインターフェースから 廃棄ホース（3.9.1.3.1） に運ぶ AGSS（3.9.1.1） の一部。

注記 1: 呼吸システム (3.6.1.1) インターフェースは、通常、専用の AGSS (3.9.1.1) 排気ポート (3.1.4.11) です。

注記2 機能的には、受信システムは過度の 真空 (3.1.1.27) が 呼吸システム (3.6.1.1) に到達するのを防ぎます。

3.9.1.3.5

転送システム

麻酔呼吸システム（3.6.1.8） の 排気ポート（3.1.4.11 ）から排気ガスを移送する移送ホース（3.9.1.3.5.1） を組み込むことができる AGSS（3.9.1.1） の一部、または関連する部分。 受信システムへの機器 (3.9.1.3.4)

3.9.1.3.5.1

トランスファーパンツ

麻酔 呼吸システム（3.6.1.8） から AGSS（3.9.1.1） 受信システム（3.9.1.3.4） に排気ガスを運ぶフレキシブルチューブ。

注記 1:移送ホースと呼吸回路の間のインターフェースは、多くの場合、ISO 5356-1 に準拠する 30 mm の円錐コネクタ (3.1.4.5) です。

3.9.1.3.6

処分流量

誘導流量

非推奨:排気流量

AGSS 廃棄システム（3.9.1.3） への入口における 受入システム（3.9.1.3.4） からのガスの流量。

注記 1:排気流量という用語の廃止は 、気道装置 (3.8.1.2) の文脈で使用される 排気流量 (3.8.1.3) との混同を避けるためです。

3.9.1.3.6.1

最大廃棄流量

非推奨:最大排気流量

指定された制限を超えずに収容できる最大の 廃棄流量（3.9.1.3.6）。

3.9.1.3.6.2

最低処理流量

大気への流出が指定された限度を超えないことを保証する 廃棄流量（3.9.1.3.6）

注記 1:この文脈では，こぼれとは ，麻酔ガス除去システム (3.9.1.1) が指定された期間に収容できない 麻酔ガス (3.1.1.5) の量である。

3.9.1.3.7

大流量処理システム

高流量移送および受入システム（3.9.1.3.8 ）で動作することを意図した AGSS 処分システム（3.9.1.3 ）。

注記 1高流量処理システムの流量要件は、ISO 7396-2 に規定されています。

3.9.1.3.8

ハイフロー受渡システム

高流量廃棄 システム（3.9.1.3.7）に接続する移送システム（3.9.1.3.5 ）及び受入システム（3.9.1.3.4 ）。

注記 1H 型（ISO 9170-2 に規定）の端末ユニット（3.2.2.1）は，大流量の移送及び受信システムでの使用を意図している。

3.9.1.3.9

低流量処理システム

低流量移送および受入システム（3.9.1.3.10 ）で動作するように意図された AGSS 処分システム（3.9.1.3 ）

注記 1低流量処理システムの流量要件は、ISO 7396-2 に規定されています。

3.9.1.3.10

低流量転送および受信システム

移送システム（3.9.1.3.5） および 低流量廃棄システム（ 3.9.1.3.9）に接続する受信システム（3.9.1.3.4 ）。

注記 1低流量の移送および受入ステーションの要件は、ISO 7396-2 に規定されています。

注記 2 タイプ 1L (ISO 9170-2 で指定) の 端末ユニット (3.2.2.1) は、 低流量の移送および受信システムでの使用を目的としています。

3.9.1.3.11

AGSS作動圧力

AGSS（3.9.1.1） ターミナルユニット（3.2.2.1）が 動作するように設計されている圧力。

3.9.1.3.12

AGSSパワーデバイス

廃棄流量（3.9.1.3.6） を生成する アクティブAGSS（3.9.1.2） のAGSS 廃棄システム （3.9.1.3）の一部。

注記 1AGSS 動力装置は，稼働中の AGSS の廃棄システムに設置された真空ポンプ，タービン又はエジェクターである (3.9.1.2) 。

3.9.1.3.13

タイプ1ターミナルユニット

使用者が接続及び切断を行うAGSS 廃棄システム（3.9.1.3） 内の 入口（3.1.4.26） アセンブリであり，準大気圧で作動する。

注記 1この定義は ISO 9170-2 および ISO 7396-2 で提供されているものから改訂され、 タイプ 2 とは対照的に、 AGSS 電源装置 (3.9.1.3.12) が パイプライン インフラストラクチャ内にあるという区別を明確にします。 AGSS電源装置が臨床室の機器の一部である 端末ユニット（3.9.1.3.14） 。

3.9.1.3.14

タイプ2ターミナルユニット

使用者が接続及び切断を行うAGSS 廃棄システム（3.9.1.3） 内の 入口（3.1.4.26） アセンブリであり，大気圧よりも高い圧力で作動する。

注記 1この定義は、ISO 9170-2 および ISO 7396-2 で提供されているものから改訂され、 AGSS 電源装置 (3.9.1.3.12) がタイプ 2 端末装置の上流にあるという区別を明確にします。 AGSS 電源装置がパイプライン インフラストラクチャの一部である タイプ 1 ターミナル ユニット (3.9.1.3.13) 。

3.9.1.4

プルーム排出システム

PES

プルーム（3.9.1.4.3） を捕捉し、輸送し、濾過し、濾過された生成物を排出するための装置。

3.9.1.4.1

中央プルーム排出システム

恒久的に設置された プルーム排出システム（3.9.1.4）。 供給システム（3.2.1.2） 、パイプラインシステム、およびターミナルユニット（3.2.2.1）を含み、 プルーム（3.9.1.4.3） を廃棄

3.9.1.4.2

キャプチャ デバイス

<プルーム排出> プルーム (3.9.1.4.3) の発生場所で プルーム排出システム (3.9.1.4) へ の 入口 (3.1.4.26) を提供するホース、チューブ、漏斗またはその他の付属品

3.9.1.4.3

飾り羽

特に、レーザー、電気外科または電気焼灼装置、広帯域光源、超音波器具、または骨のこぎり、高速ドリル、リーマーとして

3.9.1.4.3.1

レーザープルーム

ターゲットに対するレーザーエネルギーの影響によって生成される 燃焼（3.1.1.11） または熱分解のガス状および粒子状の副産物。

3.10.1.1

高真空

絶対圧が 40 kPa 未満の 真空 (3.1.1.27)

注記 1:海面では、40 kPa のしきい値は、大気圧より約 60 kPa 以上低いことに相当します。

注記 2:海面での大気圧は約 101 kPa です。

3.10.1.2

中真空

真空 (3.1.1.27) 絶対圧が 40 kPa から 80 kPa の間

注記 1:海面では、これは大気圧より 20 kPa から 60 kPa 低い範囲に相当します。

注記 2:海面での大気圧は約 101 kPa です。

3.10.1.3

低真空

絶対圧が 80 kPa を超える 真空 (3.1.1.27)

注記 1 海面では、これは大気圧より 20 kPa 低いことに相当する。

注記 2:海面での大気圧は約 101 kPa です。

3.10.1.4

断続的な真空

真空圧が自動的かつ定期的に大気圧に戻るタイプの 吸引 (3.1.1.25)

3.10.1.5

自由空気流量

指定された 入口（3.1.4.26） を通る無制限の空気の流れの速度。

3.10.1.5.1

低真空流量

自由空気流量 (3.10.1.5) 20 l/分未満

3.10.1.5.2

中真空流量

自由空気流量 (3.10.1.5) 20 l/min から 60 l/min

3.10.1.5.3

高真空流量

60 l/分を超える 自由空気流量 (3.10.1.5)

注記 1:パイプラインの設置は、必要な流量をサポートするために十分に大きな直径のチューブを使用して構築する必要があります。

3.10.1.6

排水

体腔または傷からの液体、固体粒子または気体の除去

3.10.1.6.1

胸腔ドレナージ

患者の胸腔へ の吸引（3.1.1.25） の適用による胸腔からの液体およびガスの ドレナージ（3.10.1.6）。

注記1 吸引装置の 排水（3.10.1.6） の領域外の目的では，重力の作用によるものとすることができる。

3.11.1.1

連続表示

表示 (3.1.3.7) では、モニター変数の 断続的な値 (3.11.1.2) ではなく、実際の値を表すのに十分な頻度で値が更新されます。

注記 1 この用語は，心拍の持続時間にわたって観察される圧力波形のパターンに基づいて定義される 収縮期血圧 (3.1.5.17) 値などのパラメータも指す。

3.11.1.2

間欠

<測定機器> 多数の生理的事象から単一の値を提供する生理量を推定するプロセスを利用するもの

3.11.1.3

監視装置

変数の値を測定してユーザーに示す機器または部品

注記1監視装置には， 圧力計（3.1.4.44） のように電気的に作動しない装置が含まれる。

注記2値は連続的又は断続的に表示することができる。

注記3監視装置は，主に警報状態の検出又は外部通信を目的とすることができる。

3.11.1.4

常設展示

測定値の永続的な表現

3.11.1.5

ノイズ

生理学的測定に存在する任意の周波数の不要な信号

3.11.1.6

非常設展示

測定値の非永続的な表現

3.1.3.1

accuracy

measurement accuracy

DEPRECATED:accuracy of measurement

closeness of agreement between a measured quantity and a true quantity value of a measurand

Note 1 to entry: The term accuracy, when applied to a set of test results, involves a combination of a random component and of a common systematic error or bias error (3.1.3.3) component.

Note 2 to entry: In practical terms, a reference value is commonly used with an assumption that it represents the true quantity value.

3.1.3.2

accuracy of flow

difference between the indicated flow and the actual flow

3.1.3.3

bias error

DEPRECATED:bias

difference between the expectation of the test results and an accepted reference value

Note 1 to entry:Bias error is the total systematic error as contrasted to random error. There can be one or more systematic error components contributing to the bias error. A larger systematic difference from the accepted reference value is reflected by a larger bias error value.

Note 2 to entry: Expectation is a statistical term which can be interpreted approximately as the mean of the values that would be obtained if the measurement were made many times.

3.1.3.4

calibration

operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication

3.1.3.5

calibration range

range of values over which a monitoring device or a control should be tested and verified

3.1.3.6

declared range

DEPRECATED:measurement range

portion of the displayed range (3.1.3.10) of measured values over which there is specified accuracy (3.1.3.1)

3.1.3.7

display

visual representation of quantitative or qualitative information

3.1.3.8

display update period

duration of time, or number of events (e.g. pulses), between possible changes in the displayed values

3.1.3.9

data update period

duration of time, or number of events (e.g. pulses), between possible changes in the data provided by a monitoring equipment (3.11.1.3) algorithm to the display (3.1.3.7) or to the signal input/output part

Note 1 to entry: This definition does not refer to any regular refresh period of the display (3.1.3.7) , but rather to the output of new values of the monitored parameter. The definition encompasses both that the measurement may be taken at asynchronous intervals, and also that the data transmitted to another device may be queued asynchronously due to communication bandwidth or other issues.

Note 2 to entry: A device can have more than one signal input/output part, each with its own specified data update period.

3.1.3.10

displayed range

range of values that can be displayed for a specific parameter

Note 1 to entry: The displayed range can extend beyond the declared range (3.1.3.6) .

3.1.3.11

drift

change in the reading of a measuring instrument over a stated period of time, under reference conditions that remain constant ここで, the quantity or property that is measured remains the same

3.1.3.12

laboratory accuracy

closeness of agreement between the output of a measuring device under laboratory conditions and the true value of the measurand.

Note 1 to entry:Laboratory accuracy is a qualitative concept. For a quantitative description, the term 'uncertainty' should be used.

3.1.3.13

long-term automatic mode

mode in which a timer, set by the user, initiates multiple intermittent (3.11.1.2) measurements

3.1.3.14

measuring site

part of a patient or equipment where a quantity is measured

Note 1 to entry: See also reference body site (3.1.3.17) .

3.1.3.15

normalized

displayed at constant amplitude, independent of the actual magnitude of the signal being displayed

3.1.3.16

precision

closeness of agreement between indications or measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions

Note 1 to entry: Measurement precision is usually expressed numerically by measures of imprecision, such as standard deviation, variance, or coefficient of variation under the specified conditions of measurement.

Note 2 to entry: The ‘specified conditions’ can be, for example, repeatability (3.1.3.18) conditions of measurement, intermediate precision conditions of measurement, or reproducibility conditions of measurement (see ISO 5725-1).

Note 3 to entry: Measurement precision is used to define measurement repeatability (3.1.3.18) , intermediate measurement precision, and measurement reproducibility.

Note 4 to entry: Sometimes “measurement precision” is erroneously used to mean measurement accuracy (3.1.3.1) .

Note 5 to entry:Precision depends on random errors and does not relate to the true value or the specified value.

Note 6 to entry: “Independent test results” means results obtained in a manner not influenced by any previous result on the same or similar test object. Quantitative measures of precision depend critically on the stipulated conditions. Repeatability (3.1.3.18) and reproducibility conditions are particular sets of extreme stipulated conditions.

3.1.3.17

reference body site

part of a patient to which the indicated quantity refers

Note 1 to entry: A clinical measuring device may estimate a parameter such as core temperature based on measurements from a different measuring site (3.1.3.14) , such as the ear canal.

3.1.3.18

repeatability

precision (3.1.3.16) of the same measurand carried out under the same conditions of measurement

3.1.3.19

self-measurement automatic mode

mode in which a user action initiates a limited number of intermittent (3.11.1.2) measurements

3.1.3.20

short-term automatic mode

mode in which a user action initiates a sequence of repetitive automatic intermittent (3.11.1.2) measurements within a specified time period

3.1.4.1

adaptor

specialized connector (3.1.4.5) to establish functional continuity between otherwise disparate or incompatible components

3.1.4.2

adsorber

device that removes volatile organic compounds or specified gases from a gas stream by a process of adsorption

Note 1 to entry: In specific applications an adsorber may be intended to remove a single gas, such as nitrogen from air; or a category of gases, such as odorous volatile organic compounds.

3.1.4.3

blackbody

reference temperature source of infrared radiation made in the shape of a cavity and characterized by precisely known temperature of the cavity walls and having an effective emissivity at the cavity opening as close as practical to unity

3.1.4.4

breathing tube

non-rigid tube used to convey gases or vapours within the user-detachable (3.1.4.38) section of a breathing system (3.6.1.1)

Note 1 to entry: A breathing set (3.6.1.6) typically comprises one or more breathing tubes, connectors (3.1.4.5) and other components that provide for the functions of the detachable section of a breathing system (3.6.1.1) .

3.1.4.5

connector

fitting to join two or more components

3.1.4.6

control system

device or set of devices to manage, command, direct or regulate the behaviour of other device(s) or system(s)

3.1.4.7

cuff

<airway devices> inflatable balloon permanently attached around the airway device (3.8.1.2) near the patient end (3.1.4.42) to provide a seal between the device and the patient's airway (3.8.1.1)

3.1.4.8

cuff

<blood pressure measurement> part of the automated sphygmomanometer (3.11.6.1.1) that is wrapped around the limb of the patient

3.1.4.9

equipment mount

component used to attach medical equipment to an equipment mount holder (3.1.4.9.1)

3.1.4.9.1

equipment mount holder

component of a rail system (3.1.4.50) to which an equipment mount (3.1.4.9) can be attached and detached

3.1.4.9.2

equipment mount pin

component of a rail system (3.1.4.50) used to attach medical equipment to an equipment mount pin holder (3.1.4.9.3)

3.1.4.9.3

equipment mount pin holder

component of a rail system (3.1.4.50) to which an equipment mount pin (3.1.4.9.2) can be attached and removed

3.1.4.10

port

opening(s) for the passage of a fluid through a specified interface

Note 1 to entry: A port can be in the form of a specific connector (3.1.4.5) or designed to not allow connection with any connector.

3.1.4.11

exhaust port

port (3.1.4.10) through which gas is discharged to the atmosphere or to an anaesthetic gas scavenging system (3.9.1.1)

Note 1 to entry: This definition is intentionally generic. The exhaust gas may be leaving the breathing system (3.6.1.1) , from an over-pressure relief device, or from other components.

Note 2 to entry: This term encompasses applications in which an exhaust port is connected to the input of an anaesthetic gas scavenging system (3.9.1.1) .

3.1.4.12

exhaust valve

valve with an outlet (3.1.4.40) connected to an exhaust port (3.1.4.11)

3.1.4.13

eye

lateral aperture near the end of a catheter or airway device (3.8.1.2)

3.1.4.14

flow outlet

outlet (3.1.4.40) intended to deliver a controlled flow of gas

3.1.4.15

flow-direction-sensitive component

component or accessory through which gas flow has to be in one direction only for proper functioning or patient safety

3.1.4.16

flowgauge

<medical gas supply systems> device that measures pressure and is calibrated in units of flow

Note 1 to entry: The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice (3.1.4.39)

3.1.4.17

flowmeter

equipment that measures and indicates the rate of flow of a specific gas or gas mixture

Note 1 to entry: A flowmeter can be calibrated for use within specified conditions for gas temperature, pressure, and composition.

3.1.4.18

flow-metering device

device which controls the flow of gas from an inlet connector (3.1.4.26.1) to an outlet (3.1.4.40) connector (3.1.4.5)

3.1.4.19

flow selector

means for selecting the flow and indicating the flow selected

Note 1 to entry: A flow selector can be calibrated for use within specified conditions for gas temperature, pressure, and composition.

3.1.4.20

fresh-gas inlet

port (3.1.4.10) through which fresh gas (3.1.1.16) enters the breathing system (3.6.1.1)

3.1.4.21

gas intake port

port (3.1.4.10) through which gas is drawn for use by the patient

Note 1 to entry: Gas is drawn at a sub-ambient pressure at a gas intake port, in apposition to an inlet (3.1.4.26) , at which gas is provided by a medical gas supply system (3.2.1.2) .

3.1.4.22

gas output port

DEPRECATED:inspiratory port

port (3.1.4.10) of the device through which gas is delivered at respiratory pressures (3.6.1.2) to a user-detachable (3.1.4.38) part of a breathing system (3.6.1.1)

Note 1 to entry: The gas output port of a device is where the inspiratory port (3.1.4.10) of the user-detachable (3.1.4.38) part of a breathing system (3.6.1.1) is attached.

3.1.4.23

gas return port

DEPRECATED:expiratory port

port (3.1.4.10) of the medical electrical equipment or device through which gas is returned at respiratory pressures (3.6.1.2) through an user-detachable (3.1.4.38) part of a breathing system (3.6.1.1) , from the patient-connection port (3.1.4.41)

Note 1 to entry: The gas return port of a device is where the expiratory port (3.1.4.10) of the user-detachable (3.1.4.38) part of a breathing system (3.6.1.1) is attached.

3.1.4.24

high-pressure inlet

DEPRECATED:high-pressure input port

<ventilator; respiratory therapy equipment> inlet (3.1.4.26) to which gas is supplied at a pressure exceeding 100 kPa above ambient

Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system (3.6.1.1) pressures (typically less than 10 kPa), terminal outlet (3.1.4.40) pressures (less than 600 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

3.1.4.25

hose insert

portion of a connector (3.1.4.5) which is pushed into and secured within the bore (lumen) of the hose

3.1.4.26

inlet

DEPRECATED:inlet port

DEPRECATED:input port

opening through which gas or other material is pushed by an elevated upstream pressure

Note 1 to entry:aninlet is intended for an elevated upstream pressure and therefore necessarily incorporates some form of connector (3.1.4.5) . The terms inlet port and input port have historical usage, with no change in meaning. To avoid confusion that can arise when a single concept is represented by multiple terms, these alternates are deprecated.

3.1.4.26.1

inlet connector

connector (3.1.4.5) on an inlet (3.1.4.26)

Note 1 to entry:aninlet connector can be gas-specific (3.1.2.3) , but this should be indicated with the post-coordinated term gas-specific (3.1.2.3) inlet connector.

3.1.4.27

intake

DEPRECATED:intake port

opening through which gas or other material is drawn by a sub-ambient pressure

3.1.4.28

liquid container

part of a vaporiser, nebulizer (3.7.3.1) or humidifier (3.7.2.1) that holds the liquid

Note 1 to entry: The liquid container can be accessible to the breathing gas.

Note 2 to entry: The liquid container can also be part of the humidification chamber (3.7.2.5) .

Note 3 to entry: The liquid container can be detachable for filling.

3.1.4.28.1

maximum fill volume

volume of liquid in the liquid container (3.1.4.28) when filled to its marked maximum filling level

3.1.4.29

liquid reservoir

reservoir from which the liquid container (3.1.4.28) may be replenished or which, in the absence of a liquid container, supplies liquid directly to a vaporiser or aerosol (3.1.1.3) generator

3.1.4.30

low-pressure inlet

DEPRECATED:low-pressure input port

<ventilator; respiratory therapy equipment> inlet (3.1.4.26) to which gas may be supplied at a pressure not exceeding 100 kPa above ambient

Note 1 to entry:Low-pressure input port is deprecated as a synonym as input port (3.1.4.26) is deprecated as a synonym for an inlet (3.1.4.26) .

Note 2 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system (3.6.1.1) pressures (typically less than 10 kPa), terminal outlet (3.1.4.40) pressures (less than 1 400 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

3.1.4.31

machine end

end of the device or component which is intended to be connected furthest from the patient, and closest to the source of medical gas (3.1.1.20) or vacuum (3.1.1.27)

Note 1 to entry: The machine end of a tracheal tube (3.8.3.1) is the end that connects to the patient-connection port (3.1.4.41) ; the machine end of a breathing tube (3.1.4.4) is the end that is intended to be connected to the gas output port (3.1.4.22) of a ventilator (3.4.1.1) .

3.1.4.32

maximum operating pressure

maximum pressure which a device is intended to be subjected to during normal use

3.1.4.33

medical supply unit

permanently installed medical electrical equipment intended to provide patient care infrastructure to medical areas of a healthcare facility (3.1.6.6)

Note 1 to entry: The functions provided can include electric power, telecommunications, lighting, medical gases (3.1.1.20) , liquids, plume evacuation, or anaesthetic gas scavenging.

3.1.4.34

nominal inlet pressure

upstream pressure specified by the manufacturer for which the inlet (3.1.4.26) is intended to be used

3.1.4.35

non-rebreathing valve

valve intended to prevent the inspiration of any expired gas

3.1.4.36

non-return valve

DEPRECATED:unidirectional valve

valve which permits flow in one direction only

3.1.4.37

user control

control that allows the user to cause the device to perform its intended function, without the need for tools

3.1.4.38

user-detachable

detachable without the use of a tool

3.1.4.39

orifice

<medical gas flow control> restriction of known cross-section that delivers a constant flow of gas when supplied with gas at a constant upstream pressure

3.1.4.40

outlet

opening through which gas leaves a device or component

3.1.4.41

patient-connection port

port (3.1.4.10) of a breathing system (3.6.1.1) intended for connection to an airway device (3.8.1.2)

Note 1 to entry: The patient-connection port is the end of the breathing system (3.6.1.1) proximal to the patient.

Note 2 to entry: The patient-connection port is typically a connector (3.1.4.5) suitable for connection to an airway device (3.8.1.2) such as a tracheal tube (3.8.3.1) , tracheostomy tube (3.8.5.1) , face mask (3.8.6.4) or supralaryngeal airway (3.8.2.3) .

Note 3 to entry: Current product standards typically specify that the patient-connection port is required to be in the form of specific standardized connectors (3.1.4.5), for example, a connector (3.1.4.5) conforming to ISO 5356-1.

Note 4 to entry: In anaesthetic and respiratory equipment where its function is dependent upon a design feature of the component that connects the equipment to the patient's airway (3.8.1.1) , then there is no patient-connection-port. Examples would include non-invasive ventilation using a face mask (3.8.6.4) with an integrated expiratory port (3.1.4.10) , or oxygen therapy (3.1.5.9) using an open mask (3.8.6.4) .

3.1.4.41.1

airway pressure

pressure at the patient-connection port (3.1.4.41) or at the distal outlet (3.1.4.40) of the equipment where there is no patient-connection port

Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the equipment.

3.1.4.41.2

mean airway pressure

mean value of the pressure at the patient-connection port (3.1.4.41) or at the distal outlet (3.1.4.40) of the equipment where there is no patient-connection port over a specified period

Note 1 to entry: The mean can be determined over a specified period of time, or over the period of a specified event.

Note 2 to entry: The mean airway pressure can be derived from pressure measurements made anywhere within the equipment.

3.1.4.41.3

maximum limited airway pressure

maximum limited pressure

p_lim,max

highest airway pressure (3.1.4.41.1) that can occur during normal use or under single fault condition

3.1.4.41.4

minimum limited airway pressure

minimum limited pressure

p _lim,min

lowest airway pressure (3.1.4.41.1) that can occur during normal use or under single fault condition

Note 1 to entry: The minimum limited pressure can be sub-atmospheric.

3.1.4.41.5

pressure amplitude

peak-to-trough magnitude of the pressure variation during high-frequency ventilation, as measured at the patient-connection port (3.1.4.41)

3.1.4.42

patient end

end of a device which is intended to be closest to or inserted into the patient

3.1.4.43

pressure drop

difference between the pressure measured in a gas stream flowing into a device and the pressure measured in the gas stream flowing out of the device, with a specified constant gas flowrate through the device

3.1.4.44

pressure gauge

device that measures and indicates pressure

3.1.4.45

pressure transducer

component that transforms sensed pressure into an electrical signal

3.1.4.46

pressure-relief device

pressure-relief valve

device intended to relieve excess pressure at a pre-set value

3.1.4.47

probe

connector (3.1.4.5) designed for acceptance by, and retention in, a socket (3.1.4.52)

Note 1 to entry: In anaesthesia and respiratory therapy, probes for many applications are required to be gas-specific (3.1.2.3) .

3.1.4.48

protection device

part or function of medical device or accessory that, without intervention by the user, protects the patient, other people or the environment from hazardous output due to incorrect delivery of energy or substances

3.1.4.49

quick connector

pair of type-specific components which can be easily and rapidly joined together by a single action of one or both hands without the use of tools

3.1.4.50

rail system

assembly of components comprising at least a rail, rail supports and rail clamps, and intended to secure medical equipment to a structure or other equipment

3.1.4.51

sensor

transducer

component that transforms a sensed physical or chemical quantity into an electrical signal

3.1.4.52

socket

connector (3.1.4.5) designed with one or more orifices, that accepts a mating connector which is retained within the socket’s orifice(s)

Note 1 to entry: The means of retention can be a screw thread, a mechanical latch (such as in the case of a gas-specific (3.1.2.3) probe (3.1.4.47) ), an interference fit or other means.

3.1.4.53

Y-piece

adaptor (3.1.4.1) comprising a patient-connection port (3.1.4.41) and two ports (3.1.4.10) for connection to breathing tubes (3.1.4.4)

3.1.5.1

anatomical airway

natural pathways through which respired gases pass in either direction between the atmosphere and the alveoli

3.1.5.2

blood pressure

pressure in the systemic arterial system of the body

Note 1 to entry: Pressure in the arterial system is not uniform throughout the body. Interpretation requires knowledge of the context of use including the method and site of measurement.

3.1.5.3

diastolic blood pressure

minimum value of the blood pressure (3.1.5.2) during a cardiac cycle

3.1.5.4

expiratory phase

interval from the start of expiratory flow to the start of inspiratory flow within a respiratory cycle

3.1.5.5

inspiratory phase

interval from the start of inspiratory flow to the start of expiratory flow during an unassisted breath

Note 1 to entry: This term is restricted to the designation of unassisted inspirations because, when used in relation to a breath in natural language, the verb inspire is closely associated with a patient action.

Note 2 to entry: In order to avoid any inference of ‘ventilators breathing’, the intervals during which inflations are delivered are designated as inflation phases (3.1.5.6) , see also ISO 19223.

3.1.5.6

inflation phase

interval from the start of the rise in airway pressure (3.1.4.41.1) resulting from the initiation of an inflation to the start of the expiratory flow resulting from its termination

3.1.5.7

expired tidal volume

volume of gas leaving a patient or a test apparatus during an expiratory phase (3.1.5.4)

3.1.5.8

minute volume

V _M

volume of gas per minute entering or leaving the patient’s lungs

3.1.5.9

oxygen therapy

supplemental oxygen (3.1.1.21) administered to a patient at atmospheric pressure

3.1.5.10

high flow oxygen therapy

delivery of heated humidified respirable gas at a controlled and greater than atmospheric oxygen concentration and high flow through a high-flow nasal cannula (3.8.6.3) set

Note 1 to entry: The respirable gas can be oxygen (3.1.1.21) , oxygen 93 (3.1.1.22) or a controlled mixture of air and oxygen (3.1.1.21) .

Note 2 to entry: The flow is usually intended to exceed the inspiratory flow requirements of the patient.

3.1.5.11

positive end-expiratory pressure

PEEP

positive airway pressure (3.1.4.41.1) at the end of an expiratory phase (3.1.5.4)

3.1.5.12

rebreathing

inhalation of expired gas mixture from which carbon dioxide may or may not have been removed

3.1.5.13

recruitment manoeuvre

temporary increase in the mean airway pressure (3.1.4.41.2) provided during artificial ventilation (3.4.1.2) , with or without a momentary pause of the artificial ventilation, intended to expand the lungs

Note 1 to entry: This definition is differentiated from temporary increase in mean airway pressure (3.1.4.41.2) intended to measure static compliance (3.1.1.12) of the respiratory system.

3.1.5.14

SaO₂

arterial oxygen saturation

proportion of functional haemoglobin in arterial blood that is saturated with oxygen

Note 1 to entry:SaO₂ is normally expressed as a percentage (multiplying the fraction by 100).

3.1.5.15

sigh

<ventilator> deliberate increase in delivered volume for one or a few breaths

3.1.5.16

SpO₂

arterial oxygen saturation (3.1.5.14) as estimated by a pulse oximeter (3.11.3.1)

Note 1 to entry:SpO₂ is normally expressed as a percentage (multiplying the fraction by 100).

Note 2 to entry:SpO₂ may under- or over-estimate SaO₂(3.1.5.14) due to the inability to differentiate dysfunctional forms of haemoglobin.

3.1.5.17

systolic blood pressure

maximum value of the blood pressure (3.1.5.2) during a cardiac cycle

3.1.5.18

upper airway

anatomical airway (3.1.5.1) above the laryngotracheal junction

3.1.5.19

ventilator-dependent

dependent upon artificial ventilation (3.4.1.2) in order to prevent serious deterioration of health or death

Note 1 to entry: A ventilator-dependent patient cannot breathe well enough to maintain life-sustaining levels of oxygen and carbon dioxide in the blood.

3.1.6.1

cardiopulmonary resuscitation

combination of rescue breathing and chest compressions delivered to victims thought to be in cardiac arrest

3.1.6.2

healthcare professional

individual with appropriate certification, training, knowledge and skills who provides preventive, curative, promotional or rehabilitative healthcare services in a systematic way to people, families or communities

3.1.6.3

intubation

placement of a tracheal tube (3.8.3.1) into the trachea

3.1.6.4

multiple patient multiple use

<medical device, accessory> intended by the manufacturer to be reused on multiple patients for multiple uses

Note 1 to entry: A multiple patient multiple use medical device or accessory typically requires processing (3.1.6.7) between patients.

Note 2 to entry: A multiple patient multiple use medical device or accessory may require processing (3.1.6.7) between uses on a single patient.

3.1.6.5

oxidant-enriched atmosphere

any atmosphere that contains oxidants (O₂, N₂O) in total concentration greater than 25 % of volume at ambient pressure

3.1.6.6

healthcare facility

facility where professional health services are provided

Note 1 to entry: The requirements for a healthcare facility can differ between jurisdictions.

Note 2 to entry: A healthcare facility will normally be continuously staffed by suitably trained healthcare professionals (3.1.6.2) when patients are present.

Note 3 to entry: Provision of healthcare services within a residential or other building not intended as a healthcare facility does not fall within scope of this definition, as the building is not primarily used as a healthcare facility.

3.1.6.7

processing

DEPRECATED:reprocessing

activity to prepare a new or used medical device or accessory for its intended use

Note 1 to entry:Processing includes cleaning, disinfection and sterilization (if necessary and applicable).

Note 2 to entry:Processing can be applicable to a medical device accessory.

Note 3 to entry: Such activities can occur in healthcare facilities (3.1.6.6) .

3.1.6.8

single patient multiple use

intended by the manufacturer to be reused on an individual patient for multiple uses

Note 1 to entry: A single patient multiple use medical device or accessory may require processing (3.1.6.7) between uses.

Note 2 to entry: See also single use (3.1.6.9) .

3.1.6.9

single use

intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of

Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be used again. This includes undergoing processing (3.1.6.7) .

Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to explanting the medical device.

Note 3 to entry: See also single patient multiple use (3.1.6.8) .

3.1.6.10

transport use

use during patient transport outside of a healthcare facility (3.1.6.6)

3.1.6.11

transit-operable

intended for use while being moved

3.2.2.1

terminal unit

outlet (3.1.4.40) assembly, or inlet (3.1.4.26) for vacuum (3.1.1.27) , joined to a pipeline distribution system (3.2.1.6) at which the user makes connections and disconnections

3.2.2.2

terminal unit base block

part of a terminal unit (3.2.2.1) which is attached to the medical gas (3.1.1.20) or vacuum (3.1.1.27) supply system (3.2.1.2)

3.2.2.3

terminal unit check valve

valve which remains closed until opened by insertion of an appropriate probe (3.1.4.47) and which then permits flow in either direction

3.2.2.4

terminal unit maintenance valve

valve which permits maintenance of that terminal unit (3.2.2.1) without shutting down the medical gas (3.1.1.20) or vacuum (3.1.1.27) supply system (3.2.1.2) and other terminal units (3.2.2.1)

3.2.2.5

gas-specific connection point

part of a terminal unit (3.2.2.1) or pressure outlet (3.1.4.40) which is the receptor for a gas-specific (3.1.2.3) probe (3.1.4.47)

3.2.2.6

gas-specific connector

connector (3.1.4.5) with dimensional characteristics which prevent connections between different gas services

3.2.2.7

terminal unit socket

socket (3.1.4.52) within a terminal unit (3.2.2.1) which is either integral or attached to the terminal unit base block (3.2.2.2) by a gas-specific (3.1.2.3) interface and which contains the gas-specific connection point (3.2.2.5)

3.2.2.8

maximum test pressure

maximum pressure to which a terminal unit (3.2.2.1) is designed to be subjected during pipeline pressure testing

3.2.3.1

low-pressure hose assembly

assembly consisting of a flexible hose with permanently attached gas-specific (3.1.2.3) inlet (3.1.4.26) and outlet (3.1.4.40) connectors (3.1.4.5) and designed to conduct a medical gas (3.1.1.20) at pressures less than 1 400 kPa

Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system (3.6.1.1) pressures (typically less than 10 kPa), terminal outlet (3.1.4.40) pressures (less than 1 400 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

3.2.3.2

source connector

gas-specific (3.1.2.3) part of a low-pressure hose assembly (3.2.3.1) by means of which it may be connected to the source of supply (3.2.1.3)

3.2.3.3

equipment connector

gas-specific (3.1.2.3) part of a low-pressure hose assembly (3.2.3.1) by means of which it may be connected to medical equipment

3.2.3.4

diameter-indexed safety system connector

DISS connector

range of threaded connectors (3.1.4.5) intended to maintain gas-specificity (3.1.2.3) by allocation of a set of different diameters to the mating connectors for each particular gas or service

3.2.3.5

non-interchangeable screw-threaded connector

NIST connector

range of threaded connectors (3.1.4.5) intended to maintain gas-specificity (3.1.2.3) by allocation of a set of different diameters and a left- or right-hand screw thread to mating components for each particular gas or service

3.2.3.6

hose assembly check valve

valve which is normally closed, and which allows flow in either direction when opened by the insertion of an appropriate gas-specific (3.1.2.3) connector (3.1.4.5)

3.2.4.1

pressure regulator

device which, given a variable inlet pressure, provides an outlet pressure within specified limits

3.2.4.1.1

adjustable pressure regulator

pressure regulator (3.2.4.1) which is provided with a means for user adjustment of the outlet pressure

3.2.4.1.2

closure pressure

stabilized outlet pressure, after cessation of the flow, from a pressure regulator (3.2.4.1) when the flow has been set to standard discharge

3.2.4.1.3

manifold pressure regulator

pressure regulator (3.2.4.1) intended to be installed within a source of supply (3.2.1.3) containing gas cylinders, cylinder bundles (3.2.5.2) , or high-pressure reservoirs (3.2.5.6)

3.2.4.1.4

maximum inlet pressure

maximum upstream pressure specified by the manufacturer for which the pressure regulator (3.2.4.1) is intended to be used

3.2.4.1.5

nominal outlet pressure

pressure downstream of the pressure regulator (3.2.4.1) under flow conditions specified by the manufacturer

3.2.4.1.6

preset pressure regulator

pressure regulator (3.2.4.1) that is not provided with a means of user adjustment of the outlet pressure

3.2.4.1.7

single-stage pressure regulator

pressure regulator (3.2.4.1) that reduces the inlet pressure to the required pressure in a single stage

3.2.4.1.8

two-stage pressure regulator

pressure regulator (3.2.4.1) that reduces the inlet pressure to the required pressure in two stages

3.2.5.1

content indicator

device that displays the amount of gas remaining in the gas cylinder

Note 1 to entry: The content can be expressed either in percentage of content, volume of gas or cylinder pressure.

3.2.5.2

cylinder bundle

pack or pallet of gas cylinders linked together with one or more connectors (3.1.4.5) for filling and emptying

3.2.5.3

filling port

connector (3.1.4.5) on the VIPR (3.2.5.8) through which the cylinder is filled

3.2.5.4

filling adaptor

filling tool

means of connecting the VIPR (3.2.5.8) filling port (3.2.5.3) to the filling system allowing the cylinder fitted with a VIPR to be filled or vented

Note 1 to entry: The filling tool is typically separate from the VIPR.

3.2.5.5

filling port non-return valve

valve which remains closed in normal use thus preventing the flow out of the VIPR’s (3.2.5.8) filling port (3.2.5.3) until opened by insertion of an appropriate means and which then permits flow in either direction

Note 1 to entry: Some filling port non-return valves may also be opened by the pressure of the incoming gas.

3.2.5.6

high-pressure reservoir

permanently installed container(s) with nominal working pressures of greater than or equal to 3 000 kPa at 15 °C

Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system (3.6.1.1) pressures (typically less than 10 kPa), terminal outlet pressures (less than 1 400 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

3.2.5.7

manifold

device for connecting the outlets (3.1.4.40) of one or more gas cylinders, cylinder bundles (3.2.5.2) orhigh-pressure reservoirs (3.2.5.6) of the same gas to the pipeline system

3.2.5.8

valve with integrated pressure regulator

VIPR

combination of a pressure regulator (3.2.4.1) and cylinder valve intended to be fitted to a medical gas (3.1.1.20) cylinder

3.2.5.9

working pressure

settled pressure of a compressed gas at a uniform reference temperature of 15 °C in a full gas cylinder

Note 1 to entry: This definition does not apply to liquefied gases (e.g. carbon dioxide) or dissolved gases (e.g. acetylene).

3.3.2.1

anaesthetic gas delivery system

anaesthetic workstation (3.3.1.2) component that receives separate supplies of medical gases (3.1.1.20) and delivers mixed gases in concentrations or individual flow rates adjustable by the user

Note 1 to entry: An anaesthetic gas delivery system can include a means of flow rate adjustment control, flowmeters (3.1.4.17) or a gas mixer and anaesthetic gas delivery system piping but does not include vaporisers.

3.3.2.2

anaesthetic vapour delivery system

anaesthetic vaporiser

anaesthetic workstation (3.3.1.2) component that provides the vapour of a volatile agent in a controllable concentration

3.3.2.3

draw-over vaporiser

vaporiser from which a sufficient flow of gas vapour mixture is produced by lowering the pressure at the outlet (3.1.4.40) of the vaporiser below that at its inlet (3.1.4.26) by a patient's inspiratory effort or by a ventilator (3.4.1.1)

Note 1 to entry: Air or oxygen (3.1.1.21) is commonly used as the carrier gas (3.1.1.10) .

3.3.2.4

draw-over anaesthetic system

low-resistance system for administering inhalational anaesthesia that can be used in the absence of compressed gas or electricity

3.3.2.5

draw-over valve system

valve, or combination of valves, that controls unidirectional flow to the patient during inspiration and unidirectional flow from the patient during exhalation either during spontaneous breathing or during artificial ventilation (3.4.1.2)

3.3.2.6

fresh-gas outlet

DEPRECATED:common gas outlet

port (3.1.4.10) through which fresh gas (3.1.1.16) is delivered from the anaesthetic gas delivery system (3.3.2.1)

3.3.2.7

agent-specific filling system

functional system of agent-specific (3.3.2.8) coded connections between an anaesthetic bottle and an agent-specific anaesthetic vaporiser (3.3.2.2)

3.3.2.8

agent-specific

having a prescribed configuration and prescribed dimensions which are specific for a prescribed liquid anaesthetic agent

3.3.2.9

anaesthetic bottle adaptor

assembly that is intended to connect a bottle for liquid anaesthetic agent to an agent-specific (3.3.2.8) anaesthetic vaporiser (3.3.2.2)

3.3.2.10

anaesthetic bottle collar

component on the neck of a bottle causing it to be agent-specific (3.3.2.8)

3.3.2.11

anaesthetic bottle connector

agent-specific (3.3.2.8) component that fits the thread on the bottle neck and mates with the agent-specific anaesthetic bottle collar (3.3.2.10)

3.3.2.12

anaesthetic bottle neck

external threaded part of the bottle and the adjacent contour over which an agent-specific (3.3.2.8) anaesthetic bottle collar (3.3.2.10) is fitted

3.3.2.13

filler receptacle

receptacle for a bottle or an anaesthetic bottle adaptor (3.3.2.9) on an agent-specific (3.3.2.8) anaesthetic vaporiser (3.3.2.2)

3.4.1.1

ventilator

lung ventilator

medical device or medical electrical equipment intended to provide artificial ventilation (3.4.1.2)

Note 1 to entry: In cases of possible ambiguity the full term, lung ventilator, should be used.

3.4.1.2

artificial ventilation

intermittent elevation of the pressure in the patient's airway (3.8.1.1) relative to that in the lungs by external means with the intention of augmenting or totally controlling the ventilation of a patient

3.4.1.3

anaesthetic ventilator

anaesthetic workstation (3.3.1.2) component that is connected via the anaesthetic breathing system (3.6.1.8) to the patient's airway (3.8.1.1) and automatically augments or provides ventilation during anaesthesia

3.4.1.4

EMS ventilator

ventilator (3.4.1.1) intended for use in the emergency medical services (EMS) environment

3.4.1.5

high-frequency ventilator

medical device or medical electrical equipment intended to provide ventilation of the lungs of the patient when connected to the airway (3.8.1.1) of the patient using a rate greater than 150 inflations/min

3.4.1.6

ventilator for ventilator-dependent patient

medical device or medical electrical equipment intended to augment or provide ventilation of the lungs of a ventilator-dependent (3.1.5.19) patient

3.4.1.7

ventilatory support equipment

medical device or medical electrical equipment, suitable for use in the home healthcare environment without continuous professional supervision, intended to augment or provide ventilation of the lungs of a patient who is not ventilator-dependent (3.1.5.19)

Note 1 to entry:Ventilatory support equipment is a type of ventilator (3.4.1.1) , but is not a ventilator for ventilator-dependent patient (3.4.1.6) .

Note 2 to entry: A patient suitable for ventilatory support equipment requires a narrow spectrum of ventilation modalities and monitoring for appropriate management.

3.4.1.8

resuscitator

transit-operable (3.1.6.11) equipment intended for immediate use to provide lung ventilation in the resuscitation of individuals who have sudden breathing difficulty

Note 1 to entry: National regulations may restrict this term to manually operated devices.

3.4.1.8.1

manually-cycled resuscitator

resuscitator (3.4.1.8) in which the inflation phase (3.1.5.6) and expiratory phase (3.1.5.4) are controlled by a repeated manual action of the user

Note 1 to entry: A demand valve (3.4.1.12) that can be overridden with a manual trigger is classified as a manually-cycled resuscitator incorporating a demand valve (3.4.1.12) and not as a demand valve (3.4.1.12) .

3.4.1.8.2

user-powered resuscitator

resuscitator (3.4.1.8) with which ventilation of the lungs is produced by the user squeezing its compressible unit (3.4.1.11)

3.4.1.8.3

resuscitator deadspace

volume of previously exhaled gas within the resuscitator (3.4.1.8) that is delivered to the patient in the succeeding inspiratory phase (3.1.5.5)

3.4.1.8.4

resuscitator set

pack of all the necessary components that enable the resuscitator (3.4.1.8) to be carried to the site of a resuscitation emergency and that enable the resuscitator to be made ready for immediate use

3.4.1.9

ventilator breathing system

VBS

pathways associated with a ventilator (3.4.1.1) through which gas flows to or from the patient at respiratory pressures (3.6.1.2), bounded by the port (3.1.4.10) through which fresh gas (3.1.1.16) enters, the patient-connection port (3.1.4.41) and the exhaust port (3.1.4.11)

3.4.1.10

driving gas

gas which powers a device and is not delivered to the patient

3.4.1.11

compressible unit

part of a user-powered resuscitator (3.4.1.8.2) e.g. a bag or bellows that, when compressed by the user, delivers a volume of gas

3.4.1.12

demand valve

equipment component that delivers a flow of gas related to a reduction of pressure generated by the patient at the patient-connection port (3.1.4.41)

3.4.2.1

driving-gas input port

inlet (3.1.4.26) to which the driving gas (3.4.1.10) is applied

3.4.2.2

inflating-gas input port

inlet (3.1.4.26) to which inflating gas is applied

3.4.2.3

emergency intake

DEPRECATED:emergency intake port

DEPRECATED:emergency air intake port

dedicated gasintake port (3.1.4.21) through which gas is drawn when the supply of fresh gas (3.1.1.16) or inflating gas is insufficient or absent

3.4.2.4

fresh -gas inlet connector

connector (3.1.4.5) on a ventilator breathing system (3.4.1.9) to which a fresh gas (3.1.1.16) supply is connected

3.4.3.1

continuous positive airway pressure

CPAP

positive pressure at a patient-connection port (3.1.4.41) which is applied continuously throughout the respiratory cycle

3.4.3.2

maximum working pressure

P_wmax

highest airway pressure (3.1.4.41.1) during the inspiratory phase (3.1.5.5) in normal use

3.4.3.3

minimum working pressure

P_wmin

lowest airway pressure (3.1.4.41.1) during normal use

3.4.4.1

bias flow

flow that passes through the ventilator breathing system (3.4.1.9) to the exhaust port (3.1.4.11) but is not intended to contribute to the work of lung ventilation

3.6.2.1

bag adaptor

adaptor (3.1.4.1) to one end of which the neck of an anaesthetic reservoir bag (3.6.1.3) can be attached

3.6.2.2

assembled end

end of a breathing tube (3.1.4.4) incorporating a permanently attached adaptor (3.1.4.1)

3.6.3.1

inspiratory valve

valve which, when open, allows gas to pass through it to a patient during the inspiratory phase (3.1.5.5) only

3.6.3.2

expiratory valve

valve which, when open, allows gas to pass through it from a patient during the expiratory phase (3.1.5.4) only

3.6.3.3

inspiratory-expiratory valve

single valve which performs the function of both an inspiratory valve (3.6.3.1) and an expiratory valve (3.6.3.2)

3.6.3.4

pressure-limiting device

pressure-limiting valve

means for limiting the maximum pressure within a breathing system (3.6.1.1)

3.6.3.5

APL valve

adjustable pressure-limiting valve

pop-off valve

pressure-limiting valve (3.6.3.4) with user-adjustable pressure settings

3.6.3.6

patient valve

valve in the breathing system (3.6.1.1) that directs gas to the patient-connection port (3.1.4.41) during the inspiratory phase (3.1.5.5) and into the atmosphere during the expiratory phase (3.1.5.4)

3.6.3.7

anti-asphyxia valve

valve used on a breathing mask (3.8.6.4) intended to allow spontaneous breathing when the lung ventilator (3.4.1.1) or breathing therapy equipment is not providing adequate pressure or flow

3.7.2.1

humidifier

device that adds water in the form of droplets or vapour, or both, to the inspired gas

Note 1 to entry: This term includes vaporising, bubble-through and ultrasonic humidifiers and active heat and moisture exchangers (3.7.4.1) .

3.7.2.2

active humidifier

humidifier (3.7.2.1) in which energy is added to facilitate vaporisation of water and warming of the respiratory gases

3.7.2.2.1

nebulizing humidifier

humidifier (3.7.2.1) whose output is predominantly in the droplet phase

3.7.2.2.2

vaporising humidifier

humidifier (3.7.2.1) whose output is predominantly in the vapour phase

3.7.2.3

active HME

device where water, water vapour or heat is actively added to the HME (3.7.4.1) to increase the humidity level of the gas delivered from the HME to the patient

3.7.2.4

passive humidifier

bubble–through or pass-over medical device that creates vapour or droplets from water at room temperature to moisten the inspired gas

Note 1 to entry: The chambers of passive humidifiers are at room temperature, so they have a lower humidification output (3.7.2.6) than an active humidifier (3.7.2.2) .

Note 2 to entry:Passive humidifiers do not use heat to increase the temperature of either the humidification chamber (3.7.2.5) or the breathing tubes (3.1.4.4) .

3.7.2.5

humidification chamber

part of a humidifier (3.7.2.1) in which vaporisation or nebulization takes place

3.7.2.6

humidification output

humidification system output

total mass of water vapour per unit volume of gas at the patient-connection port (3.1.4.41)

Note 1 to entry:Humidification output is expressed under body temperature and pressure saturated (3.1.1.7) conditions.

3.7.3.1

nebulizer

device that converts a liquid into an aerosol (3.1.1.3)

3.7.3.1.1

electrically-powered nebulizer

nebulizer (3.7.3.1) that operates by means of electrical power

3.7.3.1.2

manually-powered nebulizer

nebulizer (3.7.3.1) that operates by means of human power

3.7.3.1.3

gas-powered nebulizer

nebulizer (3.7.3.1) in which the aerosol (3.1.1.3) is generated by compressed gas

3.7.3.1.4

ultrasonic nebulizer

nebulizer (3.7.3.1) in which aerosol (3.1.1.3) is generated by means of ultrasound

3.7.3.1.5

breath-actuated nebulizer

nebulizer (3.7.3.1) triggered by a respiratory parameter

3.7.3.1.6

continuous nebulizer

nebulizer (3.7.3.1) in which aerosol (3.1.1.3) is delivered continuously over multiple inhalation/exhalation breathing cycles or over long periods

3.7.3.2

nebulizing system

system comprising the nebulizer (3.7.3.1) and all other components, up to and including the aerosol outlet (3.7.3.5) , required to make the aerosol (3.1.1.3) available for inhalation

3.7.3.3

aerosol output

mass or volume of aerosol (3.1.1.3) emitted by the nebulizing system (3.7.3.2) at the aerosol outlet (3.7.3.5) for the specified fill volume

3.7.3.4

aerosol output rate

mass or volume of aerosol (3.1.1.3) emitted by the nebulizing system (3.7.3.2) per unit of time

3.7.3.5

aerosol outlet

outlet (3.1.4.40) of the nebulizing system (3.7.3.2) through which the aerosol (3.1.1.3) is emitted

3.7.4.1

heat and moisture exchanger

HME

device intended to retain a portion of the patient’s expired moisture and heat, and return it to the patient's respiratory tract during inspiration

3.7.4.2

HMEF

FHME

heat and moisture exchanger (3.7.4.1) that incorporates the function of a breathing system filter (3.6.1.5)

Note 1 to entry: See also ISO 23328-1, ISO 23328-2, ISO 9360-1 and ISO 9360-2.

3.7.4.3

HME patient port

heat and moisture exchanger patient port

port (3.1.4.10) of the HME (3.7.4.1) which is intended for connection to an airway device (3.8.1.2)

3.7.4.4

HME machine port

heat and moisture exchanger machine port

port (3.1.4.10) of the HME (3.7.4.1) which is intended for connection to a breathing system (3.6.1.1) patient-connection port (3.1.4.41)

3.7.4.5

HME accessory port

heat and moisture exchanger accessory port

port (3.1.4.10) of the HME (3.7.4.1) intended for connection to an accessory

3.7.4.6

HME internal volume

heat and moisture exchanger internal volume

compressible volume contained within the HME (3.7.4.1)

Note 1 to entry: The internal volume is intended to refer to the compressible volume occupied by breathing gases.

Note 2 to entry: The internal volume is bounded by the internal surfaces of the impermeable material of the HME (3.7.4.1) , the ports (3.1.4.10) of the HME (3.7.4.1) and excludes the internal volume of female gas connectors (3.1.4.5).

Note 3 to entry: The internal volume excludes the volume of solid elements within the HME (3.7.4.1) , such as exchange media.

3.8.1.1

airway

connected, gas-containing cavities and passages within the respiratory system, that conduct gas between the alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection port (3.1.4.41) if an airway device (3.8.1.2) is used

Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a patient. Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.

3.8.1.2

airway device

device intended to provide a gas pathway to and from the patient’s airway (3.8.1.1)

3.8.1.3

exhaust flow

<airway devices> flow from the mask (3.8.6.4) or application accessory to atmosphere other than the leak due to improper seal to the face

Note 1 to entry: The exhaust flow can pass through openings in the mask (3.8.6.4) , the connecting element and the mask, or through the anti-asphyxia valve (3.6.3.7) .

Note 2 to entry: The exhaust flow discharges exhaled gases to atmosphere to reduce rebreathing (3.1.5.12) of CO₂.

3.8.1.4

swivel adaptor

specialized adaptor (3.1.4.1) which allows variation in the position of its ports (3.1.4.10) relative to each other

3.8.2.1

nasopharyngeal airway

device intended to provide a gas pathway through the nasal cavity and pharynx

3.8.2.2

oropharyngeal airway

device intended to maintain a gas pathway through the oral cavity and pharynx

3.8.2.3

supralaryngeal airway

device placed through the mouth but not through the vocal cords, which is intended to form an internal seal in the supralaryngeal area to maintain upper airway (3.1.5.18) patency

3.8.2.4

flanged end

that end of an oropharyngeal airway (3.8.2.2) which is flanged and is intended to be external to the teeth or gums

3.8.2.5

pharyngeal end

end of an oropharyngeal airway (3.8.2.2) which is intended to be inserted into a patient's oropharynx

3.8.2.6

supralaryngeal airway connector

tubular component of a supralaryngeal airway (3.8.2.3) intended for connection to a breathing system (3.6.1.1) or resuscitator (3.4.1.8)

3.8.3.1

tracheal tube

DEPRECATED:endotracheal tube

tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea

3.8.3.1.1

nasotracheal tube

tracheal tube (3.8.3.1) for insertion through the nose into the trachea

3.8.3.1.2

orotracheal tube

tracheal tube (3.8.3.1) for insertion through the mouth into the trachea

3.8.3.2

bevel

slanted portion at the patient end (3.1.4.42) of a tracheal tube (3.8.3.1)

3.8.3.2.1

angle of bevel

acute angle between the plane of the bevel (3.8.3.2) and the longitudinal axis of a tracheal tube (3.8.3.1) at the patient end (3.1.4.42)

3.8.3.3

inflating tube

tube through which the airway device (3.8.1.2) cuff (3.1.4.7) is inflated

3.8.3.3.1

inflation lumen

lumen within the wall of an airway device (3.8.1.2) for inflating a cuff (3.1.4.7)

3.8.3.4

cuff inflation device

device to inflate an airway device (3.8.1.2) cuff (3.1.4.7)

3.8.3.5

cuff pressure indicator

device which indicates to the user the intracuff pressure of an airway device (3.8.1.2) cuff (3.1.4.7)

3.8.3.5.1

automatic cuff pressure indicator

device used to automatically measure, display and control the intracuff pressure of an airway device (3.8.1.2) cuff (3.1.4.7)

3.8.3.5.2

integral cuff pressure indicator

cuff pressure indicator (3.8.3.5) that is not detachable from the airway device (3.8.1.2)

3.8.3.5.3

pilot balloon

balloon fitted to an inflating tube (3.8.3.3) to indicate inflation of the cuff (3.1.4.7)

3.8.3.6

reinforced tracheal tube

tracheal tube (3.8.3.1) whose wall incorporates additional material intended to avoid kinking

3.8.3.7

tracheal tube connector

tubular component that fits directly into the machine end (3.1.4.31) of a tracheal tube (3.8.3.1)

3.8.3.8

Murphy eye

hole through the wall of a tracheal tube (3.8.3.1) near the patient end (3.1.4.42) and on the side opposite the bevel (3.8.3.2)

3.8.3.9

Cole-type tracheal tube

tracheal tube (3.8.3.1) combining a short laryngotracheal portion (3.8.3.9.1) of small diameter and a longer oral portion (3.8.3.9.2) of larger diameter with transition from one to the other resulting in a shoulder (3.8.3.9.3)

3.8.3.9.1

laryngotracheal portion

portion of a Cole-type tracheal tube (3.8.3.9) of small diameter, extending from the bevel (3.8.3.2) tip to the point at which there is an increase in the outside diameter

3.8.3.9.2

oral portion

portion of a Cole-type tracheal tube (3.8.3.9) of large diameter, extending from the machine end (3.1.4.31) to the point at which there is a decrease in the outside diameter

3.8.3.9.3

shoulder

portion of a Cole-type tracheal tube (3.8.3.9) at which transition from the oral portion (3.8.3.9.2) to the laryngotracheal portion (3.8.3.9.1) occurs

3.8.3.10

laser-resistant tracheal tube

tracheal tube (3.8.3.1) specifically designed by the manufacturer for use during laser surgery of the airway (3.8.1.1)

Note 1 to entry: This includes devices sold preassembled or in kit form.

3.8.3.10.1

laser-resistant tracheal tube treatment

covering or surface treatment that adapts or modifies a non-laser-resistant tracheal tube (3.8.3.1) for use in laser surgery of the airway (3.8.1.1)

3.8.3.10.2

laser-resistant portion

portion of the tracheal tube (3.8.3.1) intended by the manufacturer to be laser-resistant

3.8.4.1

bronchial tube

single-lumen tube designed for insertion into a main bronchus

3.8.4.2

tracheobronchial tube

double-lumen tube designed for insertion into the trachea and a main bronchus to separate the right and left lungs

3.8.4.3

bronchus blocker

bronchial blocker

device designed for introduction through the trachea to occlude a bronchus

3.8.5.1

tracheostomy tube

tube designed for insertion into the trachea through a tracheostomy to convey gases and vapours to and from the trachea

3.8.5.2

tracheostomy tube nominal length

DEPRECATED:nominal length

distance from the patient side of the neckplate (3.8.5.5) to the patient end (3.1.4.42) along the centreline

Note 1 to entry: When the neckplate (3.8.5.5) is movable, the nominal length is variable.

3.8.5.3

tracheostomy outer tube

DEPRECATED:outer tube

part of the tracheostomy tube (3.8.5.1) which is normally in contact with the tissues

3.8.5.4

tracheostomy inner tube

DEPRECATED:inner tube

tube which fits closely to the inside contours of the tracheostomy outer tube (3.8.5.3)

3.8.5.5

neckplate

part of a tracheostomy tube (3.8.5.1) which approximates to the contour of a patient's neck and is used to secure the tube in position

3.8.5.6

neckplate lock

device by which an adjustable neckplate (3.8.5.5) is secured

3.8.5.7

tracheostomy introducer

specially adapted stylet to facilitate the introduction of the tracheostomy outer tube (3.8.5.3) into the trachea

3.8.6.1

integral nasal cannula

low-flow nasal cannula (3.8.6.2) and therapy tubing with no user-detachable (3.1.4.38) connectors (3.1.4.5) between the inlet connector (3.1.4.26.1) and the nasal prongs

3.8.6.2

low-flow nasal cannula

patient interface comprising nasal prongs designed for the administration of oxygen (3.1.1.21) below an appropriate threshold for the patient size

Note 1 to entry: A flow of less than 6 l/min is considered as low flow for adults. For paediatric patients, a lower threshold might be applicable.

3.8.6.3

high-flow nasal cannula

patient interface comprising nasal prongs designed for the administration of oxygen (3.1.1.21) or fresh gas (3.1.1.16) above an appropriate threshold for the patient size.

Note 1 to entry: A flow of greater than 6 l/min is considered as high flow for adults. For paediatric patients, a lower threshold might be applicable.

3.8.6.4

mask

device which provides a non-invasive interface between the patient’s airway (3.8.1.1) and a patient-connection port (3.1.4.41) or other connection to a source of respirable gas

3.8.6.5

user-detachable nasal cannula

low-flow nasal cannula (3.8.6.2) with connections between the inlet connector (3.1.4.26.1) and the nasal prongs that can be detached by the user

3.8.7.1

voice prosthesis

a medical device, introduced into a tracheoesophageal puncture (TEP), that allows expiratory airflow into the oesophagus for tracheoesophageal speech, but prevents the leakage of fluids into the airway (3.8.1.1)

3.8.7.2

flange dimension

main dimension of the tracheal and oesophageal flanges of a voice prosthesis (3.8.7.1)

3.8.8.1

laryngoscope blade

rigid laryngoscope component shaped to provide a direct view of the larynx

3.8.8.1.1

fibre-illuminated blade

laryngoscope blade (3.8.8.1) incorporating optical fibres to transmit light from a source to illuminate the larynx

3.8.8.1.2

conventional laryngoscope blade

detachable laryngoscope blade (3.8.8.1.3) incorporating a lamp, positioned to provide direct illumination of the larynx during use, and having an electrical connection to the handle in the hook-on fitting

3.8.8.1.3

detachable laryngoscope blade

laryngoscope blade (3.8.8.1) that can be separated from a handle by the user

3.8.8.2

single-piece laryngoscope

laryngoscope with a handle and non-detachable blade

3.10.2.1

vacuum regulator

device for controlling the applied vacuum level (3.10.2.3)

3.10.2.2

vacuum level indicator

device for displaying the vacuum level (3.10.2.3)

3.10.2.3

vacuum level

vacuum pressure expressed as an amount less than atmospheric pressure

3.10.2.4

manually powered suction

generation of vacuum (3.1.1.27) by direct human effort

3.10.2.5

collection container

container in which liquids and solid particles are collected

3.10.2.6

collection container assembly

collection container (3.10.2.5) and its closure with connectors (3.1.4.5) for suction (3.1.1.25)

3.10.2.7

overfill protection device

device intended to prevent liquid and solid particles entering the intermediate suction tubing (3.10.2.10)

3.10.2.8

suction end piece

part of the suction (3.1.1.25) equipment applied to the patient, which begins at the site where material is drawn in and ends at the first detachable connection

3.10.2.9

suction tubing

tubing for conduction of liquids, solid particles or gas from the suction end piece (3.10.2.8) to the collection container (3.10.2.5)

3.10.2.10

intermediate suction tubing

tubing between the collection container (3.10.2.5) and the vacuum (3.1.1.27) source

3.10.3.1

suction catheter

flexible tube designed for introduction into the respiratory tract or an airway device (3.8.1.2) to remove material by suction (3.1.1.25)

3.10.3.2

closed suction catheter

suction catheter (3.10.3.1) enclosed within a protective sleeve that allows its use within the airway (3.8.1.1) without opening the breathing system (3.6.1.1) directly to atmosphere

3.10.3.3

closed suction catheter manifold

part of the closed suction catheter (3.10.3.2) that provides a connection to an airway device (3.8.1.2)

3.10.3.4

suction catheter connector

connector (3.1.4.5) at the machine end (3.1.4.31) of the suction catheter (3.10.3.1) that allows a connection to suction tubing (3.10.2.9)

3.10.3.5

suction catheter shaft

part of a suction catheter (3.10.3.1) which is of uniform outside diameter

3.10.3.6

suction catheter tip

patient end (3.1.4.42) of a suction catheter (3.10.3.1)

3.10.3.7

suction control device

means provided at or near the machine end (3.1.4.31) of a suction catheter (3.10.3.1) to control the level of suction (3.1.1.25) in the suction catheter

3.10.3.8

terminal orifice

central aperture at the patient end (3.1.4.42) of a suction catheter (3.10.3.1)

3.11.2.1

respiratory gas monitor

RGM

medical electrical equipment intended to measure the gas level (3.11.2.6) orpartial pressure (3.1.1.22) of one or more gases in respiratory gas

Note 1 to entry: The respiratory gas monitor consists of equipment, as specified in the accompanying documents for the intended use of the RGM, including a sensor (3.1.4.51) , display (3.1.3.7) , alarm system, accessories and, for a diverting RGM (3.11.2.2) , the sampling tube (3.11.2.5) and exhaust tube.

3.11.2.2

diverting RGM

sidestream RGM

RGM (3.11.2.1) which transports a portion of respiratory gases from the sampling site (3.11.2.4) through a sampling tube (3.11.2.5) to the sensor (3.1.4.51) , which is remote from the sampling site

3.11.2.3

non-diverting RGM

mainstream RGM

RGM (3.11.2.1) which uses a sensor (3.1.4.51) at the sampling site (3.11.2.4)

3.11.2.4

sampling site

location of the sensor (3.1.4.51) for a non-diverting RGM (3.11.2.3) or location at which respiratory gases are diverted for measurement to a remote sensor for a diverting RGM (3.11.2.2)

3.11.2.5

sampling tube

conduit for the transfer of gas from the sampling site (3.11.2.4) to the sensor (3.1.4.51) in a diverting RGM (3.11.2.2)

3.11.2.6

gas level

content of a specific gas in a gaseous mixture

Note 1 to entry: Expressed as a volumetric concentration or as a partial pressure (3.1.1.23) .

Note 2 to entry:Gas level is widely used as a synonym for concentration in respiratory gas monitoring.

3.11.2.7

oxygen analyser

monitoring equipment (3.11.1.3) intended solely for the determination of the concentration of oxygen in a gaseous mixture

Note 1 to entry:anoxygen analyser can be integral to a lung ventilator (3.4.1.1) , anaesthetic workstation (3.3.1.2) , medical gas pipeline system (3.2.1.1) or other equipment.

3.11.2.8

capnometer

RGM (3.11.2.1) intended to measure the carbon dioxide gas level (3.11.2.6) in respiratory gases

3.11.3.1

pulse oximeter

pulse oximeter equipment

medical electrical equipment for the non-invasive estimation of functional oxygen saturation of arterial haemoglobin ( SpO₂(3.1.5.16) ) from a light signal interacting with tissue, by using the time-dependent changes in tissue optical properties that occur with pulsatile blood flow

Note 1 to entry:Pulse oximeter equipment comprises a pulse oximeter monitor, a probe cable extender, if provided, and a pulse oximeter probe (3.11.3.1.1) , which can be combined in a single assembly.

3.11.3.1.1

pulse oximeter probe

component containing the part of a pulse oximeter (3.11.3.1) intended to come in direct contact with a patient

Note 1 to entry: For some pulse oximeters (3.11.3.1) , the probe may be considered an accessory.

3.11.3.1.2

pulse oximeter probe fault

abnormal condition of the pulse oximeter probe (3.11.3.1.1) or probe cable extender that, if not detected, could cause patient harm

Note 1 to entry: Patient harm can be caused by providing incorrect values, by exposing the patient to high pulse oximeter probe (3.11.3.1.1) temperatures or by introducing a risk of electric shock.

3.11.3.2

controlled desaturation study

hypoxaemia induced in a human subject under laboratory conditions

Note 1 to entry: This can also be referred to as a controlled hypoxaemia (breathdown) study.

3.11.3.3

co-oximeter

multiwavelength optical blood analyser that measures total haemoglobin (3.11.3.4) concentration and the concentrations of various haemoglobin derivatives

Note 1 to entry: The relevant co-oximetry value is functional saturation of arterial blood, SaO₂(3.1.5.14) , which pulse oximeter equipment (3.11.3.1) estimates and reports as SpO₂(3.1.5.16) .

3.11.3.4

total haemoglobin

sum of all types of haemoglobin including, but not limited to, oxyhaemoglobin, methaemoglobin, deoxyhaemoglobin and carboxyhaemoglobin

3.11.4.1

clinical thermometer

equipment used for taking measurements at a specified measuring site (3.1.3.14) and indicating the temperature at the reference body site (3.1.3.17)

Note 1 to entry: The measuring site (3.1.3.14) can be the same as the reference body site (3.1.3.17) .

3.11.4.2

adjusted mode

<thermometry> operating mode where the output temperature is calculated by adjusting the signal from the input sensor (3.1.4.51)

Note 1 to entry: For the purposes of this standard, emissivity is considered a thermal or physiological property of the measuring site (3.1.3.14) , i.e. any clinical thermometer (3.11.4.1) utilizing radiance that is dependent on emissivity is considered to operate in an adjusted mode.

3.11.4.3

calibration source

<thermometry> infrared blackbody (3.1.4.3) of known and traceable temperature and emissivity

3.11.4.4

limits of agreement

<thermometry> the magnitude of a potential disagreement between outputs of two clinical thermometers (3.11.4.1) equal to double the standard deviation of output temperature differences when used on the same human subjects

Note 1 to entry:Limits of agreement can also be described as clinical uncertainty.

3.11.4.5

skin temperature

skin surface temperature as measured from the workable target plane of a thermograph, with an appropriate adjustment for skin emissivity

Note 1 to entry: The emissivity of dry human skin is accepted to be 0,98.

3.11.5.1

electrocardiogram

ECG

graphical presentation or digital recording of cardiac activity over time using one or more ECG leads (3.11.5.4)

3.11.5.2

ECG equipment

medical electrical equipment or system that continuously acquires and stores an ECG (3.11.5.1) signal from the body surface of a patient and analyses, displays, or transmits the resultant data for the purpose of interpreting the cardiac rhythm or conduction of the ECG signal for the purposes of diagnosis or treatment of the patient

3.11.5.2.1

ambulatory ECG recorder

medical electrical equipment connected to the patient including associated ECG electrodes (3.11.5.3) and cables for recording an ECG (3.11.5.1) signal from an ambulatory patient

Note 1 to entry:anambulatory ECG recorder may also analyse the heart action potentials. It may record selectively when significant events are detected, or continuously.

3.11.5.2.2

diagnostic ECG equipment

ECG equipment (3.11.5.2) intended for the acquisition of 12 or more ECG leads (3.11.5.4) for diagnostic purposes

Note 1 to entry: This includes any device which has multiple purposes and includes production of a 12-lead ECG for diagnostic purposes in the intended use.

3.11.5.2.3

monitoring ECG equipment

ECG equipment (3.11.5.2) intended for monitoring the cardiac activity of one patient, including displaying ECG (3.11.5.1) , displaying measurements such as heart rate, and generating alarm indications based on analysis of the ECG.

Note 1 to entry: This includes any device which has multiple purposes and includes monitoring the cardiac activity of a patient in the intended use.

Note 2 to entry: An ECG (3.11.5.1) telemetry transmitter and receiver including its associated display (3.1.3.7) of one patient’s data forms an ECG equipment (3.11.5.2) . ECG telemetry is typically used to display that data of a patient at a remote location. Implementations of these remote displays frequently display data from several patients at the same time, but logically separate the data of each patient on such a display.

3.11.5.3

ECG electrode

sensor (3.1.4.51) in contact with a specified part of the body to detect electrical cardiac activity

3.11.5.3.1

disposable ECG electrode

ECG electrode (3.11.5.3) designed for single use (3.1.6.9) that is adhered to the patient body surface and has a conductive interface

3.11.5.3.2

ECG electrode impedance

combined measure of the opposition to current through the ECG electrode (3.11.5.3) interface (resistance) and of the ability to store charge at the interface (capacitive reactance), in response to a current

Note 1 to entry: An alternating current is used to measure both components of resistance.

3.11.5.3.3

ECG electrode offset stability

rate of change in DC offset voltage (3.11.5.7) over a time due to variations in the half-cell potential of the ECG electrode (3.11.5.3)

3.11.5.3.4

ECG electrode system

device composed of a sensing element and an electrolyte provided with the sensing element by the manufacturer or specified by the manufacturer

Note 1 to entry: Alternative technologies include dry ECG electrodes (3.11.5.3) and new conductive interfaces technologies also exist that may be used as the sensing interface.

Note 2 to entry: Conventional sensing elements may be pre-gelled ECG electrodes (3.11.5.3) or be a conductive semisolid, or it may require application of an electrolyte by the end user (non-pre-gelled ECG electrodes).

3.11.5.3.5

cable and lead wire assembly

assembly of individual wires or trunk cable that connects the patient to the ECG equipment (3.11.5.2)

Note 1 to entry: Typically, this consists of a trunk cable and a set of lead wires, which may be separable from the trunk cable (3.11.5.3.6) or may be integrated as a single assembly into the trunk cable.

3.11.5.3.6

trunk cable

portion of the cable and lead wire assembly (3.11.5.3.5) within which all wires are bundled together in one jacket or are in some way bound permanently together and used to connect the ECG lead wires (3.11.5.4.2) to the ECG equipment (3.11.5.2)

Note 1 to entry: Individual ECG lead wires (3.11.5.4.2) may be bonded together, for example as a ribbon cable, in which case the lead wires and trunk cable are one assembly that does not have a trunk cable yoke (3.11.5.3.7) .

3.11.5.3.7

trunk cable yoke

end of the trunk cable (3.11.5.3.6) into which all the ECG lead wires (3.11.5.4.2) connect

3.11.5.4

ECG lead

voltage between ECG electrodes (3.11.5.3)

3.11.5.4.1

ECG lead selector

system to select certain ECG leads (3.11.5.4)

3.11.5.4.2

ECG lead wire

individual wire connected between an ECG electrode (3.11.5.3) and either a trunk cable yoke (3.11.5.3.7) or the ECG equipment (3.11.5.2)

Note 1 to entry: Individual ECG lead wires may be bonded together, for example as a ribbon cable, in which case the lead wires and trunk cable (3.11.5.3.6) are one assembly that does not have a trunk cable yoke (3.11.5.3.7) .

3.11.5.4.3

ECG lead wire connector

connector (3.1.4.5) that attaches an ECG lead wire (3.11.5.4.2) to the trunk cable yoke (3.11.5.3.7)

3.11.5.5

neutral ECG electrode

reference ECG electrode

reference point for differential amplifiers or interference suppression circuits, not intended to be used to calculate any ECG lead (3.11.5.4)

3.11.5.6

common mode rejection

CMR

ability of the ECG equipment (3.11.5.2) including the trunk cable (3.11.5.3.6) and ECG electrodes (3.11.5.3) , high frequency filters, protection networks, amplifier input, etc., to discriminate between signals with differences between amplifier inputs (differential signal) and signals common to the amplifier inputs (common signal), in the presence of an ECG electrode impedance imbalance

3.11.5.7

DC offset voltage

potential difference across a pair of ECG electrodes (3.11.5.3) due to the difference in their ECG electrode half-cell potentials

3.11.5.8

ECG report

output data from a recorded ECG (3.11.5.1) , which may be in the form of a permanent display (3.11.1.4) output (hard copy), non-permanent display (3.11.1.6) output or a stored digital record

Note 1 to entry: The output data includes the ECG (3.11.5.1) , and may additionally contain associated data such as the date and time that ECG was acquired, patient identification, ECG acquisition parameters, and computerized analysis results, etc.

3.11.5.9

heart rate variability

HRV

statistical results calculated from consecutive RR intervals

3.11.6.1

sphygmomanometer

equipment for non-invasive estimation of systemic arterial blood pressure (3.1.5.2)

3.11.6.1.1

automated sphygmomanometer

medical electrical equipment used for the non-invasive estimation of the blood pressure (3.1.5.2) by utilizing an inflatable cuff (3.1.4.8) , a pressure transducer (3.1.4.45) , a valve for deflation, and displays (3.1.3.7) used in conjunction with automatic methods for determining blood pressure

Note 1 to entry: Components of an automated sphygmomanometer include manometer, cuff (3.1.4.8) , valve for deflation (often in combination with the valve for rapidly exhausting the pneumatic system), pump for inflation of the bladder, and connection tubing.

3.11.6.1.2

non-automated sphygmomanometer

equipment used for the non-invasive measurement of the blood pressure (3.1.5.2) by utilizing an inflatable cuff (3.1.4.8) with a pressure-sensing element, a valve for deflation, and display (3.1.3.7) used in conjunction with a stethoscope or other manual methods for estimating blood pressure

Note 1 to entry: Components of these instruments include manometer, cuff (3.1.4.8) , valve for deflation (often in combination with the valve for rapidly exhausting the pneumatic system), hand pump or electro-mechanical pump for inflation of the bladder, and connection tubing. A non-automated sphygmomanometer can also contain electro-mechanical components for pressure control.

3.11.6.2

BP cuff bladder

part of the blood pressure (3.1.5.2) cuff (3.1.4.8) that is inflatable

3.11.6.3

mean arterial pressure

value of the integral of one heartbeat cycle of the blood pressure (3.1.5.2) curve divided by the time of that cycle

Note 1 to entry: Because of hydrostatic effects, this value should be determined with the cuff (3.1.4.8) at the level of the heart.

3.11.6.4

non-invasive blood pressure measurement

indirect measurement of the blood pressure (3.1.5.2) without arterial puncture

3.11.7.1

transcutaneous partial pressure monitor

medical electrical equipment and associated transducers (3.1.4.51) for the monitoring of partial pressures (3.1.1.23) of oxygen or carbon dioxide at the skin surface